Longitudinal Quality of Life Study Among Participants With AIDS-Associated Kaposi Sarcoma at Bugando Medical Centre, in Mwanza, Tanzania
Conditions: AIDS-Related Kaposi Sarcoma, Human Immunodeficiency Virus 1 Positive
Sponsor: AIDS Malignancy Consortium

AMC-S007 (Version 2.0) 20MAR2018 
 
 
i 
NCI Version Date 20MAR2018 
SUMMARY OF CHANGES 
 
Longitudinal Quality of Life Study among Participants with AIDS-Associated Kaposi 
Sarcoma at Bugando Medical Centre, in Mwanza, Tanzania 
Version 2.0 
 
NCI Protocol #: AMC-S007 
Local Protocol #: AMC-S007 
 
NCI Version Date: 20MAR2018 
Protocol Date: 20MAR2018 
 
# 
Section 
Comments 
1. 
Global 
Changed from: 
Version 1.0, 21NOV2017 
NCI Version 21NOV2017 
 
Changed to: 
Version 2.0, 20MAR2018 
NCI Version 20MAR2018 
2. 
Global 
Changed from: 
Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) 
 
Changed to: 
Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) 
3. 
6.3.3 
Changed from: 
Death due to progressive disease should be reported as Grade 5 “Neoplasms benign, 
malignant and unspecified (incl cysts and polyps) - Other (Progressive Disease)” under 
the system organ class (SOC) of the same name. Evidence that the death was a 
manifestation of underlying disease (e.g., radiological changes suggesting tumor growth or 
progression: clinical deterioration associated with a disease process) should be submitted. 
 
Changed to: 
Death due to progressive disease should be reported as Grade 5 “General disorders and 
administration site conditions – Disease Progression”. Evidence that the death was a 
manifestation of underlying disease (e.g., radiological changes suggesting tumor growth or 
progression: clinical deterioration associated with a disease process) should be submitted. 
4. 
6.3.4 
Changed from: 
Pregnancy reporting and outcomes will be documented by completion of the appropriate 
CRFs, including the Adverse Event form. 
 
Changed to: 
Pregnancy reporting and outcomes will be documented by completion of the appropriate 
CRFs, including the Adverse Event form, using the appropriate term in the system organ 
class (SOC) for Pregnancy, puerperium and perinatal conditions. 
 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
ii 
NCI Version Date 20MAR2018 
# 
Section 
Comments 
5. 
8.1.5 
Changed from: 
Complete blood cell counts with differentials and platelets, and serum liver/renal function 
analysis. This should include the following: albumin, alkaline phosphatase, total bilirubin, 
bicarbonate, BUN, calcium, chloride, creatinine, glucose, LDH, phosphorus, potassium, 
total protein, SGOT [AST], SGPT [ALT], sodium. 
 
Changed to: 
Complete blood cell counts with differentials and platelets, and serum liver/renal function 
analysis. This should include the following: total and direct bilirubin, creatinine, SGOT 
[AST], SGPT [ALT]. 
6. 
Appendix I 
Changed from: 
Instructions: In the event that the participant’s condition is deteriorating, laboratory 
evaluations should be repeated within 24 hours before initiation of the next cycle of therapy. 
 
Footnote a: Albumin, alkaline phosphatase, total bilirubin, bicarbonate, BUN, calcium, 
chloride, creatinine, glucose, LDH, phosphorus, potassium, total protein, SGOT [AST], 
SGPT [ALT], sodium. 
 
Changed to: 
Instructions: If the participant’s condition is deteriorating, laboratory evaluations should be 
repeated within 24 hours before initiation of the next cycle of therapy. 
 
Footnote a: Total and direct bilirubin, creatinine, SGOT [AST], SGPT [ALT]. 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
1 
NCI Version Date 20MAR2018 
 
AIDS MALIGNANCY CONSORTIUM 
 
AMC PROTOCOL #S007: 
Longitudinal Quality of Life Study Among Participants with 
AIDS-Associated Kaposi Sarcoma at Bugando Medical Centre, in 
Mwanza, Tanzania 
A Trial of the AIDS Malignancy Consortium (AMC) 
 
Sponsored by: 
National Cancer Institute 
Office of HIV and AIDS Malignancy (OHAM) 
 
NCT Registration Number: 
TBD 
 
Regulatory Status: 
Subject to Review by the BMC/CUHAS Research Ethics 
Committee and the Tanzanian National Institute for 
Medical Research (NIMR) 
 
Commercially Available 
Agents:  
Bleomycin (NSC 125066) 
Vincristine sulfate (NSC 67574) 
 
Protocol Chair: 
Kristin Schroeder, MD, MPH 
 
Protocol Co-Chair: 
Nestory Masalu, MD, MMed 
Version 2.0 
20 March 2018 
NCI Version 20 March 2018 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
2 
NCI Version Date 20MAR2018 
AMC PROTOCOL SIGNATURE PAGE 
 
I, Nestory Masalu, Principal Investigator at site Bugando Medical Centre agree to conduct and 
follow this protocol: AMC Protocol #S007 – Longitudinal Quality of Life Study Among 
Participants with AIDS-Associated Kaposi Sarcoma at Bugando Medical Centre, in 
Mwanza, Tanzania (Version 2.0, 20MAR2018), as written according to AMC, NCI, and 
National Institute for Medical Research (NIMR) guidelines. I understand that no deviations from 
the protocol eligibility criteria or waivers for protocol deviations will be permitted. 
 
 
 
_________________________________ 
 
______________________ 
Signature 
Date (dd/mmm/yyyy) 
 
 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
3 
NCI Version Date 20MAR2018 
TABLE OF CONTENTS 
SUMMARY OF CHANGES ......................................................................................................... i 
AMC PROTOCOL SIGNATURE PAGE ...................................................................................2 
TABLE OF CONTENTS ..............................................................................................................3 
LIST OF TABLES AND FIGURES .............................................................................................5 
PROTOCOL ROSTER .................................................................................................................6 
PROTOCOL SYNOPSIS ..............................................................................................................7 
PROTOCOL SCHEMA ................................................................................................................8 
ABBREVIATIONS LIST ..............................................................................................................9 
1.0 
OBJECTIVES ..................................................................................................................11 
1.1 
Primary Objective ..................................................................................................11 
1.2 
Secondary Objective ..............................................................................................11 
1.3 
Exploratory Objective ............................................................................................11 
2.0 
BACKGROUND ..............................................................................................................12 
2.1 
Study Disease .........................................................................................................12 
2.2 
Treatment Regimen ................................................................................................12 
2.3 
Study Design and Rationale ...................................................................................12 
3.0 
PARTICIPANT SELECTION .......................................................................................14 
3.1 
Eligibility Criteria ..................................................................................................14 
3.2 
Exclusion Criteria ..................................................................................................15 
3.3 
Number of Participants to be Enrolled...................................................................16 
3.4 
Participant Enrollment Procedures ........................................................................16 
4.0 
TREATMENT PLAN ......................................................................................................17 
4.1 
Treatment Administration ......................................................................................17 
4.2 
Concomitant Medication and Supportive Care Guidelines ...................................18 
4.3 
Duration of Therapy ...............................................................................................19 
4.4 
Duration of Follow Up ...........................................................................................20 
5.0 
DOSING DELAYS/DOSE MODIFICATIONS ............................................................21 
5.1 
Dose Modifications for BV ....................................................................................21 
5.2 
Dose Modifications for Vincristine .......................................................................23 
5.3 
Dose Modifications for Bleomycin ........................................................................24 
6.0 
ADVERSE EVENTS: LIST AND REPORTING REQUIREMENTS .......................26 
6.1 
Adverse Events and Potential Risks Lists ..............................................................26 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
4 
NCI Version Date 20MAR2018 
6.2 
Classification of AEs by Severity and Relationship to Treatment 
Administration .......................................................................................................26 
6.3 
Expedited Adverse Event Reporting ......................................................................28 
6.4 
Routine Adverse Event Reporting .........................................................................29 
6.5 
Secondary Malignancy...........................................................................................30 
6.6 
Second Malignancy ................................................................................................30 
7.0 
PHARMACEUTICAL INFORMATION ......................................................................31 
7.1 
Study Product Preparation .....................................................................................31 
8.0 
CLINICAL AND LABORATORY EVALUATIONS ..................................................34 
8.1 
Screening/Baseline Evaluations .............................................................................34 
8.2 
Evaluations during Treatment ................................................................................34 
8.3 
Treatment Discontinuation Evaluations .................................................................35 
8.4 
Final Evaluations, Off Study..................................................................................35 
9.0 
MEASUREMENT OF EFFECT ....................................................................................36 
9.1 
Definition of Response ..........................................................................................36 
10.0 
STATISTICAL CONSIDERATIONS ...........................................................................39 
10.1 
Study Design/Endpoints.........................................................................................39 
10.2 
Sample Size/Accrual Rate ......................................................................................39 
11.0 
ROLE OF DATA MANAGEMENT ..............................................................................40 
11.1 
CRF Instructions ....................................................................................................40 
11.2 
Data Quality ...........................................................................................................40 
11.3 
Data Monitoring .....................................................................................................40 
12.0 
ETHICAL AND REGULATORY CONSIDERATIONS ............................................41 
12.1 
IRB Approval and Informed Consent ....................................................................41 
12.2 
Changes to the Protocol .........................................................................................41 
12.3 
Women and Minorities ..........................................................................................41 
13.0 
REFERENCES .................................................................................................................43 
APPENDIX I: SCHEDULE OF EVALUATIONS ...................................................................44 
APPENDIX II: PERFORMANCE STATUS SCALES ............................................................45 
APPENDIX III: AMC DATA AND SAFETY MONITORING PLAN ..................................46 
APPENDIX IV: FACT-G QUESTIONNAIRE, VERSION 4, ENGLISH AND SWAHILI .49 
 
 
 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
5 
NCI Version Date 20MAR2018 
LIST OF TABLES AND FIGURES 
Table 4-A: Treatment Administration .......................................................................................17 
Table 5-A: Dose Modifications for BV - Nausea .......................................................................21 
Table 5-B: Dose Modifications for BV - Vomiting ....................................................................21 
Table 5-C: Dose Modifications for BV - Anemia ......................................................................22 
Table 5-D: Dose Modifications for BV - Neutropenia ..............................................................22 
Table 5-E: Dose Modifications for BV - Thrombocytopenia ...................................................23 
Table 5-F: Dose Modifications for Vincristine – Peripheral Neuropathy ..............................23 
Table 5-G: Dose Modifications for Vincristine – Constipation or Ileus .................................24 
Table 5-H: Elevated Total Bilirubin ..........................................................................................24 
Table 5-I: Dose Modifications for Bleomycin – Pulmonary Toxicity......................................25 
Table 5-J: Dose Modifications for Bleomycin – Renal Insufficiency ......................................25 
Table 6-A: Adverse Event List for Vincristine..........................................................................26 
Table 6-B: Adverse Event List for Bleomycin ...........................................................................26 
Table 6-C: Attribution .................................................................................................................28 
Table 12-A: Accrual Targets.......................................................................................................42 
 
 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
6 
NCI Version Date 20MAR2018 
PROTOCOL ROSTER 
AMC Protocol #S007 
Longitudinal Quality of Life Study Among Participants with AIDS-Associated Kaposi 
Sarcoma at Bugando Medical Centre, in Mwanza, Tanzania 
 
Protocol Chair: 
Kristin Schroeder MD, MPH 
AIDS Malignancy Consortium 
P.O. Box 1370 
Mwanza, Tanzania 
Tel: 255-686-3-86349 
Email: kristin.schroeder@dm.duke.edu 
Protocol Statistician: 
Jeannette Y. Lee, PhD 
AMC Statistical Center 
University of Arkansas for Medical Sciences 
4301 W. Markham, #781 
Little Rock, Arkansas 72205-7199 
Tel: (501) 526-6712 
Fax: (501) 526-6729 
Email: JYLee@uams.edu 
Protocol Co-Chair: 
Nestory Masalu MD, MMed 
Bugando Medical Centre 
P.O. Box 1370 
Mwanza, Tanzania 
Tel: 255-783-0-00004 
Email: nmasaslu4@gmail.com 
Data Management/Operations: 
AMC Operations and Data Management 
Center 
The Emmes Corporation 
401 N. Washington Street, Suite 700 
Rockville, MD 20850 
Tel: (301) 251-1161 
Fax: (240) 238-2842 
Email: amipm@emmes.com 
AMC Kaposi Sarcoma Working Group 
Chair: 
Lee Ratner, MD, PhD 
Washington University School of Medicine 
Division of Oncology  
660 S. Euclid Avenue  
Campus Box 8069  
St. Louis, MO 63110 
Tel: 314-362-8836 
Fax: 314-747-2120 
Email: lratner@dom.wustl.edu 
 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
7 
NCI Version Date 20MAR2018 
PROTOCOL SYNOPSIS 
 
TITLE: 
Longitudinal Quality of Life Study Among Participants with 
AIDS-Associated Kaposi Sarcoma at Bugando Medical Centre, 
in Mwanza, Tanzania 
PHASE OF STUDY: 
Pilot 
PARTICIPATING 
INSTITUTIONS: 
This protocol will be open at the Bugando Medical Centre in 
Mwanza, Tanzania 
ACCRUAL TARGET: 
Minimum: 12, Maximum: 20 
POPULATION: 
Participants with KS who are HIV-positive initiating 
chemotherapy with bleomycin and vincristine sulfate (BV). See 
Section 3.0 for eligibility criteria. 
REGIMEN: 
Participants will receive standard therapy for KS: bleomycin (15 
units/m2) and vincristine (2mg fixed dose) infused intravenously 
every 21 days for a maximum of six cycles. A Quality of Life 
(QOL) survey, the Functional Assessment of Cancer Therapy-
General (FACT-G), will be administered at baseline, after 3 and 
6 cycles of treatment (cycle 4 and treatment discontinuation), and 
at 3 months after treatment discontinuation. 
DURATION: 
7 months 
PRIMARY OBJECTIVE: To evaluate the longitudinal quality of life of participants with 
HIV-associated KS during treatment with vincristine and 
bleomycin at a single institution in East Africa. 
SECONDARY 
OBJECTIVE: 
To explore baseline and time-dependent correlates of 
improvements in quality of life. 
EXPLORATORY 
OBJECTIVE: 
To assess quality control (completeness and accuracy) in data 
capture of adverse events, clinical benefit, and objective response 
for site evaluation and training purposes. 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
8 
NCI Version Date 20MAR2018 
PROTOCOL SCHEMA 
 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
9 
NCI Version Date 20MAR2018 
ABBREVIATIONS LIST 
ABV 
adriamycin, bleomycin, and vincristine 
AE 
adverse event 
AERS 
Adverse Event Reporting System 
AIDS 
acquired immunodeficiency syndrome 
ALT 
alanine aminotransferase 
AMC 
AIDS Malignancy Consortium 
AML 
acute myelocytic leukemia  
ANC 
absolute neutrophil count 
ART 
antiretroviral therapy 
AST 
aspartate aminotransferase 
BIP 
bleomycin-induced pneumonitis 
BMC 
Bugando Medical Centre 
BV 
bleomycin and vincristine sulfate 
cART 
combined antiretroviral therapy 
CBC 
complete blood count 
CDC 
Centers for Disease Control and Prevention 
CDUS 
Clinical Data Update System 
COPD 
chronic obstructive pulmonary disease 
CR 
complete response 
CRF 
case report form 
CT 
computed tomography 
CTCAE 
Common Terminology Criteria for Adverse Events 
CTEP 
Cancer Therapy Evaluation Program 
CTMS 
Clinical Trials Monitoring Service 
CXR 
chest x-ray 
DHHS 
Department of Health and Human Services 
DNA 
deoxyribonucleic acid 
ECOG 
Eastern Cooperative Oncology Group 
FACT-G 
Functional Assessment of Cancer Therapy-General 
FCBP 
female of childbearing potential 
FDA 
Food and Drug Administration 
G-CSF 
granulocyte colony stimulating factor 
HAART 
highly active antiretroviral therapy 
HHV-8 
human herpesvirus-8 
HIV 
human immunodeficiency virus 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
10 
NCI Version Date 20MAR2018 
ICH 
International Conference on Harmonisation 
IDB 
Investigational Drug Branch 
IEC 
institutional ethics committee 
IND 
investigational new drug 
INR 
international normalized ratio 
IRB 
institutional review board 
KPS 
Karnofsky performance status 
KS 
Kaposi sarcoma 
KSHV 
Kaposi sarcoma-associated herpesvirus 
LFT 
liver function test 
LLN 
lower limit of normal 
MDS 
myelodysplastic syndrome 
MOP 
manual of procedures 
NCI 
National Cancer Institute 
NIMR 
National Institute for Medical Research 
NRTI 
nucleoside reverse transcriptase inhibitor 
ODMC 
Operations and Data Management Center 
OHAM 
Office of HIV and AIDS Malignancy 
OTC 
over the counter 
PCP 
Pneumocystis jirovecii pneumonia 
PD 
progressive disease 
PI 
principal investigator 
PIO 
Protocol Information Office 
PLD 
pegylated liposomal doxorubicin 
PN 
peripheral neuropathy 
PR 
partial response 
prn 
pro re nata (as needed) 
QOL 
quality of life 
RNA 
ribonucleic acid 
SAE 
serious adverse event 
SD 
stable disease 
SGOT 
serum glutamic oxaloacetic transaminase 
SGPT 
serum glutamic pyruvic transaminase 
SOC 
System Organ Class 
ULN 
upper limit of normal 
WHO 
World Health Organization 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
11 
NCI Version Date 20MAR2018 
1.0 
OBJECTIVES 
1.1 
Primary Objective 
To evaluate the longitudinal quality of life of participants with HIV-associated KS during 
treatment with bleomycin and vincristine at a single institution in East Africa. 
1.2 
Secondary Objective 
To explore baseline and time-dependent correlates of improvements in quality of life 
(QOL). 
1.3 
Exploratory Objective 
To assess quality control (completeness and accuracy) in data capture of adverse events, 
clinical benefit, and objective response for site evaluation and training purposes. 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
12 
NCI Version Date 20MAR2018 
2.0 
BACKGROUND 
2.1 
Study Disease 
Kaposi sarcoma (KS) is a vascular inflammatory tumor of endothelial origin caused by 
Kaposi sarcoma-associated herpesvirus (KSHV), also known as human herpesvirus 8 
(HHV-8).1 HIV infection and immunosuppression dramatically increase the risk of KS 
among people infected with KSHV. 
KS is the most common malignancy seen in patients with human immunodeficiency virus 
infection. The incidence of HIV associated KS remains high in parts of Africa where rates 
of both HIV and HHV-8 infection are high, but treatment options are often limited. In high 
resource countries, treatment for advanced AIDS-associated KS, in addition to 
antiretroviral treatment, typically includes chemotherapy.2-8 While chemotherapy has been 
shown to reduce the burden of disease, it has not been shown to alter survival outcomes. 
The goal of treatment is palliation and improvement in quality of life (QOL). However, in 
low resource countries, such as Tanzania, the optimal treatment and the effect of treatment 
on quality of life is unknown. 
2.2 
Treatment Regimen 
2.2.1 Bleomycin and vincristine 
This study will only use standard of care drugs for the treatment of KS. The 
selection of bleomycin and vincristine sulfate (BV), and its choice over another 
regimen available in Tanzania, adriamycin, bleomycin, and vincristine (ABV), was 
based on several considerations. First, the large, randomized, controlled trials of 
liposomal anthracyclines versus BV or ABV were all conducted pre-highly active 
antiretroviral therapy (HAART). For example, in the randomized trial that 
compared pegylated liposomal doxorubicin (PLD) and BV reported by Stewart et 
al., only half of the patients in each arm of the study were receiving any 
antiretroviral therapy (ART), and ART was confined to single or combination 
nucleoside reverse transcriptase inhibitors (NRTIs).2 
In studies that have used rigorous response criteria, there was no evidence that BV 
was inferior to ABV with respect to objective, strictly defined response rates.2-4 On 
the other hand, there was good evidence that BV had a superior toxicity profile 
compared to ABV, which was associated with a higher rate of hematologic toxicity 
and treatment delays for neutropenia and infection and also presents the risk of 
serious cardiotoxicity. In addition, as noted by Stewart et al.,2 BV was also 
associated with considerably less myelosuppression than PLD, which may be 
particularly important in locales where hematopoietic growth factors like 
granulocyte-colony stimulating factor (G-CSF) are not available and where access 
to blood component transfusion is limited. 
2.3 
Study Design and Rationale 
HIV seroprevalence among Tanzanians age 15-49 is estimated at 5.1%,9 resulting in 
approximately 2.2 million HIV-positive persons within the country. Little is known about 
either the rate of objective response of KS to standard chemotherapy in this setting or its 
influence on QOL. Bugando Medical Centre (BMC) is a provisional AMC site and the 
current proposal is exploratory and intended to develop clinical research and database 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
13 
NCI Version Date 20MAR2018 
management capacity. Additionally, knowledge of both the objective response rate to the 
current standard therapy and its influence on QOL, using a standardized questionnaire 
validated in Swahili, would be useful before embarking on clinical trials of other treatments 
for KS conducted with the AMC. 
This is a prospective observational study to evaluate the quality of life of participants 
receiving BV for HIV-associated KS at a single institution in Tanzania. All participants 
presenting for care of HIV-associated KS at BMC during a 1-year study period will be 
approached for enrollment. 
At enrollment, KS stage, clinical symptoms, CD4 count, complete blood count (CBC), 
liver, and renal function labs, and history of opportunistic infection will be recorded. The 
extent of KS will be evaluated at baseline and after each cycle of treatment, and response 
assessed using standard AMC criteria. The Functional Assessment of Cancer Therapy-
General (FACT-G) QOL questionnaire has been used successfully in HIV-associated 
clinical trials to collect data in 4 categories: physical, emotional, functional, and social 
wellbeing. A Swahili version has been validated and will be used in the current proposal.5 
This questionnaire will be completed at four time points: prior to initiating treatment, after 
3 cycles, at the end of therapy, and 3 months off therapy. 
Participants will receive institutional standard of care treatment with BV, administered on 
day one of each 21-day chemotherapy cycle. Vincristine sulfate will be administered at a 
dose of 2 mg (fixed dose) over 1 minute into the sidearm of a rapidly flowing intravenous 
infusion every 3 weeks. The vincristine infusion will be followed by bleomycin 
administered at a dose of 15 units/m2 over 10 minutes every 3 weeks. 
Treatment with BV will continue for six cycles or until toxicity requiring discontinuation 
of chemotherapy, or the local physician determines that alternative therapy is required, 
whichever occurs first. 
Institutional standard pre-treatment staging evaluation includes chest X-ray and physical 
history and exam. Complete blood cell counts, and serum liver/ renal function analysis will 
be required at each pretreatment visit. Other clinical or laboratory evaluations will be 
performed as deemed necessary by the medical provider. Clinical benefit, objective tumor 
response, and toxicity will be assessed every 3 weeks, prior to initiating each new 
chemotherapy cycle. 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
14 
NCI Version Date 20MAR2018 
3.0 
PARTICIPANT SELECTION 
A CTEP-registered investigator (Dr. Nestory Masalu or Dr. Kristin Schroeder) will 
document that each protocol participant meets all stated eligibility criteria. Satisfaction of 
eligibility requirement will be documented prior to participant enrollment. In compliance 
with CTEP policy, no exceptions to eligibility criteria will be granted under any 
circumstance. 
NOTE: Institutions may use this section of the protocol as an eligibility checklist for source 
documentation if it has been reviewed, signed, and dated before registration/randomization 
by the study investigator. If used as source documentation, this checklist must be printed, 
the investigator must check each item to document their assessment that the participant 
meets each eligibility criterion, and the completed checklist must be maintained in the 
participant’s chart. 
Participant ID Number: S007- ___ ___ ___ - ___ ___ ___ ___ ___ 
Patient’s Initials (L, F, M): ___ ___ ___ 
3.1 
Eligibility Criteria 
____ 3.1.1 HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or 
chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry 
and confirmed by a licensed Western blot or a second antibody test by a method 
other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 
RNA viral load. 
NOTE: The term “licensed” refers to a U.S. FDA-approved kit or for sites located 
in countries other than the U.S., a kit that has been certified or licensed by an 
oversight body within that country and validated internally. 
World Health Organization (WHO) and Centers for Disease Control and Prevention 
(CDC) guidelines mandate that confirmation of the initial test result must use a test 
that is different from the one used for the initial assessment. A reactive initial rapid 
test should be confirmed by either another type of rapid assay or an E/CIA that is 
based on a different antigen preparation and/or different test principle (e.g., indirect 
versus competitive), or a Western blot or a plasma HIV-1 ribonucleic acid (RNA) 
viral load. 
____ 3.1.2 Participants must have pathologically confirmed Kaposi sarcoma. 
____ 3.1.3 Participants should not have had prior therapy for their Kaposi sarcoma. 
____ 3.1.4 All participants must be on stable antiretroviral therapy (ART) for a minimum of 
12 weeks prior to study entry with an acceptable regimen that adheres to national 
guidelines for treatment of HIV infection. 
____ 3.1.5 Age ≥18 years. Because no dosing or adverse event data are currently available on 
the use of BV in participants <18 years of age, children are excluded from this 
study. 
____ 3.1.6 ECOG performance status ≤ 2 (Karnofsky performance status ≥ 50%, see Appendix 
II). 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
15 
NCI Version Date 20MAR2018 
____ 3.1.7 Participants must have organ and marrow function within the following parameters 
within 7 days of enrollment: 
• Leukocytes: ≥ 3,000/mm3 
• Absolute neutrophil count: ≥ 1,000/mm3 
• Hemoglobin ≥ 8 g/dL 
• Platelets: ≥ 75,000/mm3 
• Direct bilirubin: < 3mg/dL 
• AST (SGOT) / ALT (SGPT): ≤ 2.5 X institutional upper limit of normal 
• Creatinine: 
o Creatinine levels within normal institutional limits; or, 
o Creatinine clearance ≥ 60 mL/min/1.73 m2 for participants with creatinine 
levels above institutional normal 
____ 3.1.8 Participants with serious chronic, acute, or recurrent infections must have 
completed at least 14 days of therapy prior to enrollment and be clinically stable. 
____ 3.1.9 If the participant is a female of childbearing potential (FCBP), defined as a sexually 
mature woman who: (1) has not undergone a hysterectomy or bilateral 
oophorectomy, or (2) has not been naturally postmenopausal for at least 24 
consecutive months (i.e., has had menses at any time in the preceding 24 
consecutive months), the participant must have a negative urine or serum pregnancy 
test within 1 week prior to enrollment and agree to use an effective form of 
contraception (e.g., barrier contraception or hormonal contraception), during the 5 
months of planned chemotherapy treatment and for 6 months after completing 
treatment. 
____ 3.1.10 Ability to understand and the willingness to sign a written informed consent 
document. 
3.2 
Exclusion Criteria 
Participants who do not fulfill the criteria as listed in Section 3.1 above, are ineligible. 
Additionally, the presence of any of the following conditions will exclude a participant 
from study enrollment: 
____ 3.2.1 Participants who are receiving any other investigational agents. 
____ 3.2.2 Participants with known brain metastases should be excluded from this clinical trial 
because of their poor prognosis and because they often develop progressive 
neurologic dysfunction that would confound the evaluation of neurologic and other 
adverse events. 
____ 3.2.3 History of allergic reactions attributed to compounds of similar chemical or 
biologic composition to bleomycin or vincristine. 
____ 3.2.4 Uncontrolled intercurrent illness including, but not limited to, ongoing or active 
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac 
arrhythmia, or psychiatric illness/social situations that would limit compliance with 
study requirements. 
____ 3.2.5 Participants who are breastfeeding a child. Because there is an unknown but 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
16 
NCI Version Date 20MAR2018 
potential risk for adverse events in nursing infants secondary to treatment of the 
mother with BV, breastfeeding should be discontinued if the mother is treated with 
this chemotherapy. 
____ 3.2.6 Current or history of known pulmonary fibrosis, chronic obstructive pulmonary 
disease (COPD), emphysema, bronchiectasis, or diffuse or significant local 
radiographic interstitial infiltrates on chest x-ray (CXR) or computed axial 
tomography (CT) scan, that, in the opinion of the investigator, would exclude 
bleomycin use. 
NOTE: Participants with an abnormal CXR or CT scan (which may indicate 
pulmonary KS) should undergo screening evaluations to rule out an infectious 
cause, per standard of care. If available, other diagnostic procedures such as 
bronchoscopy should be considered to confirm the presence or absence of 
pulmonary KS and/or an infectious agent. These procedures should be 
completed outside the study. These participants should be excluded if, in the 
opinion of the site investigator, use of bleomycin would be detrimental. 
____ 3.2.7 Oxygen saturation less than 90% and/or exercise desaturation greater than 4% 
within 14 days before study enrollment. 
NOTE: Exercise is defined as any activity that will increase a participant’s resting 
heart rate by at least 20 beats/minute. 
3.3 
Number of Participants to be Enrolled 
3.3.1 Proposed sample size 
This study will enroll up to 20 participants. 
3.3.2 Accrual rate 
Approximately 2 participants per month. 
3.4 
Participant Enrollment Procedures 
This protocol must be approved by the Institutional Review Board (IRB), the National 
Institute for Medical Research (NIMR) in Tanzania, and the participating site must be 
registered for study participation with the AMC Operations and Data Management Center 
(ODMC) before participant enrollment. 
After it has been determined that the participant is eligible and an informed consent form 
has been signed by the participant, the participant must be registered on-line via the AMC 
Internet Data Entry System (Advantage eClinical). Enrollment and data collection will 
occur via Advantage eClinical. 
The participating site will ensure a participant meets all eligibility criteria prior to 
completing the protocol-specific eligibility checklist in Advantage eClinical for 
enrollment. Participants will be enrolled on-line via Advantage eClinical no more than 1 
week prior to the initiation of treatment (enrollment 1 day prior to or on the day of treatment 
is strongly encouraged). Once the eligibility checklist is submitted a system-generated 
confirmation email will be sent to the enroller upon successful completion of the participant 
enrollment. If the on-line system is inaccessible, the site should notify the AMC ODMC 
(via email at amipm@emmes.com or via phone at 301-251-1161) for further instructions. 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
17 
NCI Version Date 20MAR2018 
4.0 
TREATMENT PLAN 
The treatment plan (Section 4.0) and dose modifications (Section 5.0) and clinical and 
laboratory evaluations (Section 8.0) presented in this protocol represent the standard of 
care for KS treatment at Bugando Medical Centre. As the primary aim of this investigation 
is to assess quality of life, this treatment plan represents the general guidelines the site will 
follow for patient care concurrent to survey assessments required by this protocol. 
Excepting cases where enrolled participants do not receive any doses of standard of care 
chemotherapy and therefore cannot be assessed for the effect of treatment on quality of 
life, adherence to the treatment plan will not be assessed for this protocol. 
4.1 
Treatment Administration 
Standard treatment will be administered on an outpatient basis. Reported adverse events 
and potential risks for bleomycin and vincristine are described in Section 6.0. Appropriate 
dose modifications for bleomycin and vincristine are described in Section 5.0. No 
investigational or commercial agents or therapies other than those described below may be 
administered with the intent to treat the participant's malignancy. 
Table 4-A: Treatment Administration 
Drug 
Dose 
Route 
Schedule 
Vincristine 
sulfate (V) 
2 
mg 
in 
2mL 
(undiluted) 
IV 
over 
1 
minute 
(maximum 2 minutes) 
Every 21 days for up 
to six cycles 
Bleomycin 
sulfate (B) 
15 units/m2 in 50 mL 
0.9% sodium chloride 
for injection 
IV over 10 minutes  
Every 21 days for up 
to six cycles 
4.1.1 Standard therapy dosing instructions 
BV will be administered on day 1 of each 21-day cycle. 
Each cycle of BV should be administered 21 days (±2 days) after the first day of 
the previous cycle. BV must not be administered earlier than 19 days after the 
previous cycle. 
Treatment with BV will continue for six cycles, or until toxicity requiring 
discontinuation of study chemotherapy, or the site investigator has determined that 
alternative therapy is required, whichever occurs first. 
4.1.1.1 Vincristine sulfate will be administered at a dose of 2 mg (fixed dose) in a 
volume of 2 mL over 1 minute into the sidearm of a rapidly flowing 
intravenous infusion every 21 days (±2 days) (see Section 5.2.2 for specific 
instructions regarding dosage reduction for participants with elevated 
bilirubin). The vincristine infusion will be followed by bleomycin as 
detailed below. 
4.1.1.2 Vincristine should be administered before bleomycin if given in the same 
IV line. 
4.1.1.3 Bleomycin sulfate will be administered at a dose of 15 units/m2 over 10 
minutes every 21 days (±2 days) (see Section 5.3 for specific instructions 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
18 
NCI Version Date 20MAR2018 
regarding dosage reduction for participants whose creatinine clearance falls 
below 60 mL/min). 
Maximum cumulative lifetime total dose of bleomycin is 400 units. 
4.1.2 See Section 5.0 for specific instructions regarding dosage modification for 
participants. 
4.2 
Concomitant Medication and Supportive Care Guidelines 
4.2.1 General 
In general, concomitant medications and therapies deemed necessary for the 
supportive care and safety of the participant, including transfusions of blood and 
blood products, antibiotics, and antiemetics when appropriate, are allowed. 
Warfarin/coumarin anticoagulants: Avoid if possible. Use often causes an elevation 
or fluctuation in the INR. In the first instance consider switching participant to a 
low molecular weight heparin during treatment or if the participant continues taking 
an oral anticoagulant monitor the INR at least once a week and adjust dose 
accordingly. 
The administration of any other therapies intended to treat KS including 
chemotherapy and biologic agents is NOT permitted. The use of other concurrent 
investigational drugs is not allowed. 
The following categories of concurrent medications will be recorded in 
AdvantageEDC: 
• All antiretroviral drugs 
• Anti-infective drugs 
• Hematopoietic colony stimulating factors 
• Any drugs used to treat KS symptoms (e.g., analgesics) or treatment-related 
adverse events. 
• Any disallowed medications 
4.2.2 Bleomycin 
Mucositis 
Skin and mucosal changes are the most frequent side effects, occurring in 
approximately 50% of treated patients and are dose-related. Topical steroids may 
be useful. Skin ulceration and/or peeling on fingertips may be painful and can 
require discontinuation of bleomycin. 
Skin Pigmentation 
Bleomycin can cause unusual pigmentation on the trunk consisting of linear streaks 
with crisscross patterns in 8-20% of patients. 
Fever 
Fever and chills occur in approximately 50% of patients. These reactions usually 
occur starting a few hours after treatment, and may last up to 4-12 hours. Pre-
treatment with hydrocortisone 100 mg IV significantly decreases severity of the 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
19 
NCI Version Date 20MAR2018 
reaction. Acetaminophen q3-4h prn can be used to control fever if it occurs. 
4.2.3 Vincristine 
Peripheral neuropathy 
Neurotoxicity is dose- and exposure-related, with increased toxicity in prolonged 
infusion. Neurotoxicity is generally reversible, but recovery may be slow. The most 
frequent manifestation of nervous system toxicity is peripheral neuropathy, the 
earliest indication of which is the depression of the Achilles reflex. Later loss of 
other deep tendon reflexes occurs and is accompanied by peripheral paresthesias, 
pain, and tingling. Cranial nerve neuropathy may lead to vocal cord paresis or 
paralysis (hoarseness, weak voice), ocular motor nerve dysfunction (ptosis, 
strabismus), bilateral facial nerve palsies, or jaw pain. Treatment of neuropathy 
symptoms may be offered as available in line with local standard of care. If a 
participant is receiving an ART drug associated with peripheral neuropathy (PN), 
stopping that particular drug and switching to an alternative nucleoside reverse 
transcriptase inhibitor (NRTI) is recommended, where available. 
Severe jaw pain can occur within a few hours of the first dose of vincristine, and 
can be treated with acetaminophen or pain medications. 
Constipation 
Constipation (which can be severe) is due to autonomic neuropathy, presenting as 
abdominal pain, urinary retention and paralytic ileus. Laxatives or stool softeners 
should be given routinely to prevent constipation. These symptoms resolve with 
time and may not occur with subsequent treatment. 
4.2.4 Other 
Infectious and disease related complications will be managed per institutional 
protocol per primary HIV care team.  
4.3 
Duration of Therapy 
In the absence of treatment delays due to adverse event(s), treatment may continue for 6 
cycles or until one of the following criteria applies: 
• Disease progression, 
• Intercurrent illness that prevents further administration of treatment, 
• Unacceptable adverse event(s), 
• Participant decides to withdraw from the study, or 
• General or specific changes in the participant's condition render the participant 
unacceptable for further treatment in the judgment of the investigator 
• Participant non-compliance 
• Pregnancy 
o All women of child bearing potential should be instructed to contact the investigator 
immediately if they suspect they might be pregnant (e.g., missed or late menstrual 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
20 
NCI Version Date 20MAR2018 
period) at any time during study participation. 
o The investigator must immediately notify CTEP in the event of a confirmed 
pregnancy in a participant in the study. 
• Termination of the study by sponsor. 
• The drug manufacturer(s) no longer manufacture the drugs. 
4.4 
Duration of Follow Up 
All participants will be followed for 12 weeks after removal from protocol treatment or 
until death, whichever occurs first. Participants who discontinue study participation will be 
able to continue prescribed chemotherapy off protocol per institutional standard of care. 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
21 
NCI Version Date 20MAR2018 
5.0 
DOSING DELAYS/DOSE MODIFICATIONS 
Except as noted below, if an adverse event requiring a delay in chemotherapy does not 
recover to the level required for continued chemotherapy treatment within 3 weeks of the 
scheduled date of the next cycle (i.e., within 42 days after the start of the previous cycle), 
chemotherapy should be discontinued. 
In any case in which the dose of prescribed chemotherapy is reduced due to toxicity, any 
future dosing (for that cycle and all subsequent cycles) should be at the reduced dose unless 
otherwise noted. 
5.1 
Dose Modifications for BV 
Table 5-A: Dose Modifications for BV - Nausea 
Event Name 
Nausea 
Grade of Event 
Management/Next Dose  
≤ Grade 1 
No change in next dose. 
Grade 2 
No change in next dose. Increase supportive antiemetics. 
Grade 3/4 
Delay start of cycle * until < Grade 2. Increase supportive 
antiemetics. 
*Participants requiring a delay of >2 weeks should go off protocol therapy. 
Participants requiring > two dose reductions should go off protocol therapy. 
Recommended management: antiemetics. 
 
Table 5-B: Dose Modifications for BV - Vomiting 
Event Name 
Vomiting 
Grade of Event 
Management/Next Dose  
≤ Grade 1 
No change in next dose 
Grade 2 
No change in next dose. Increase supportive antiemetics 
Grade 3 
Delay start of cycle* until < Grade 2. Increase supportive 
antiemetics 
Grade 4 
Off protocol therapy 
*Participants requiring a delay of > 2 weeks should go off protocol therapy. 
Participants requiring > two dose reductions should go off protocol therapy. 
Recommended management: antiemetics. 
 
 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
22 
NCI Version Date 20MAR2018 
Table 5-C: Dose Modifications for BV - Anemia 
Event Name 
Anemia 
Grade of Event 
Management/Next Dose  
≤ Grade 1 
(LLN - 10g/dL) 
No change in next dose 
Grade 2 
(< 10 - 8.0 g/dL) 
No change in next dose 
Grade 3 – 4 
(< 8 g/dL) 
Red blood cell transfusion is recommended to increase the 
hemoglobin level to ≥ 8.0 g/dL. Chemotherapy can 
continue for hemoglobin < 8.0 – 6.5 g/dL. 
For hemoglobin < 6.5 g/dL, chemotherapy should be held 
and the participant transfused with red blood cells until the 
hemoglobin level has returned to ≥ 8.0 g/dL. Study 
medication may then be resumed at full dose. 
If hemoglobin < 6.5 g/dL recurs after resumption of 
chemotherapy, the participant should again be transfused 
as above. Chemotherapy may then be resumed as follows: 
25% reduction in the dose of both drugs. 
Participants requiring > two dose reductions should go off protocol therapy. 
 
Table 5-D: Dose Modifications for BV - Neutropenia 
Event Name 
Neutropenia 
Grade of Event 
Management/Next Dose  
≤ Grade 1 
(LLN-1500/mm3) 
No change in next dose 
Grade 2 
(< 1500-1000/mm3) 
No change in next dose 
Grade 3 
(< 1000-500/mm3) 
Delay start of cycle * until < Grade 3. No change in next 
dose. If delayed a second time, decrease bleomycin by 
25%. ** 
Grade 4 
(< 500/mm3) 
Delay start of cycle * until < Grade 3. Resume but 
decrease bleomycin dose 25%. *** 
*Participants requiring a delay of > 2 weeks should go off protocol therapy. 
**Participants requiring > two dose reductions should go off protocol therapy. 
*** Febrile neutropenia: ANC < 0.5x109/L plus fever requiring hospitalization, 
reduce dose to 11mg/m2 for all future BV therapy. 
 
 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
23 
NCI Version Date 20MAR2018 
Table 5-E: Dose Modifications for BV - Thrombocytopenia 
Event Name 
Thrombocytopenia 
Grade of Event 
Management/Next Dose  
≤ Grade 1 (LLN-
75,000/mm3) 
No change in next dose 
Grade 2 (< 75,000-
50,000/mm3 
No change in next dose 
Grade 3 (< 50,000- 
25,000/mm3) 
Delay start of cycle * until > 50,000. Resume at 50% 
dosing of bleomycin. 
Grade 4 (< 25,000) 
Delay start of cycle * until < Grade 2. Resume at 50% 
dosing of bleomycin. ** 
*Participants requiring a delay of > 2 weeks should go off protocol therapy. 
**Participants requiring > two dose reductions should go off protocol therapy. 
 
5.2 
Dose Modifications for Vincristine 
5.2.1 Peripheral neuropathy 
 
Table 5-F: Dose Modifications for Vincristine – Peripheral Neuropathy 
Event Name 
Peripheral Neuropathy 
Grade of Event 
Management/Next Dose  
Grade 1-2 
No change in next dose. Treatment of neuropathy 
symptoms may be offered as available in line with 
local standard of care. If a participant is receiving an 
ART drug associated with peripheral neuropathy (PN), 
stopping that particular drug and switching to an 
alternative nucleoside reverse transcriptase inhibitor 
(NRTI) is recommended, where available. 
Grade 3-4   
Discontinue vincristine. Symptomatic treatments to 
treat neuropathy symptoms may be offered as 
available in line with local standard of care. 
 
 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
24 
NCI Version Date 20MAR2018 
Table 5-G: Dose Modifications for Vincristine – Constipation or Ileus 
Event Name 
Constipation or Ileus 
Grade of Event 
Management/Next Dose  
Grade 1-2 
No change in next dose. Treatment of 
constipation symptoms may be offered as 
available in line with local standard of care.  
Grade 3-4 
Hold dose; institute aggressive regimen to treat 
constipation if present. When symptoms reduce to ≤ 
grade 3 resume at 50% of calculated dose (maximum 
dose: 1 mg) and escalate to full dose as tolerated. 
Participants requiring > two dose reductions should go off protocol 
therapy. 
 
5.2.2 Elevated total bilirubin 
 
Table 5-H: Elevated Total Bilirubin 
Event Name 
Elevated Total Bilirubin 
Grade of Event 
Management/Next Dose for Vincristine 
Grade 1 
No change in next dose 
Grade 2  
50 % dosing of baseline dose of vincristine* 
Grade 3 
25% dosing of baseline dose of vincristine* 
Grade 4 
Off protocol therapy 
* If bilirubin within normal range after reduced dose, may rechallenge 
with next dose increment for subsequent cycle. 
 
5.3 
Dose Modifications for Bleomycin 
5.3.1 Pulmonary toxicity 
Participants with bleomycin induced pneumonitis (BIP) present initially with a 
nonproductive cough, exertional dyspnea, and sometimes fever. Participants should be 
questioned carefully for new dry unproductive cough or new respiratory limitation of 
exercise tolerance at each visit. Persistence of either of these symptoms for longer than 
one week without other explanation, such as infection, should prompt consideration of 
BIP. A normal chest x-ray is unreliable to exclude BIP. Evaluate for infectious causes per 
institutional standard and consider antibiotic use if appropriate. If infections are excluded, 
the administration of corticosteroids is indicated. 
 
 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
25 
NCI Version Date 20MAR2018 
Table 5-I: Dose Modifications for Bleomycin – Pulmonary Toxicity 
Event Name 
Pulmonary Toxicity 
Grade of Event 
Management/Next Dose  
Grade 1-2 
Hold and investigate*. If confirmed treat with corticosteroids. If a greater 
than 4% decrease in oxygen saturation develops or persists after 
treatment of an intercurrent infection, such as Pneumocystis 
jirovecii pneumonia (PCP), then bleomycin will be permanently 
discontinued. 
Grade 3 
Decrease subsequent dose to 75%. If a greater than 4% decrease in 
oxygen saturation develops or persists after treatment of an 
intercurrent infection, such as Pneumocystis jirovecii pneumonia 
(PCP), then bleomycin will be permanently discontinued. 
Grade 4 
Discontinue. 
* Duration of hold must not exceed 21 days after scheduled dose 
 
5.3.2 Renal Insufficiency 
Table 5-J: Dose Modifications for Bleomycin – Renal Insufficiency 
Event Name 
Renal Insufficiency 
Creatinine clearance (mL/min) 
Percent of baseline bleomycin dose 
>/= 50 
100% 
40 – 50 
70% 
30 – 40 
60% 
20 – 30 
55% 
10 – 20 
45% 
5 – 10 
40% 
 
 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
26 
NCI Version Date 20MAR2018 
6.0 
ADVERSE EVENTS: LIST AND REPORTING REQUIREMENTS 
AE monitoring and reporting is a routine part of every clinical trial. The following list of 
AEs (Section 6.1) and the characteristics of an observed AE (Section 6.2) will determine 
whether the event requires expedited reporting in addition to routine reporting (via 
Advantage eClinical). All adverse event reporting will be conducted via Advantage 
eClinical for this protocol. 
The CTEP Version 5.0 of the NCI Common Terminology Criteria for Adverse Events 
(CTCAE) will be utilized for AE reporting. The CTEP Version 5.0 of the CTCAE is 
identified and located on the CTEP website at 
http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm. 
All appropriate treatment areas should have access to a copy of the CTEP Version 5.0 of 
CTCAE. 
6.1 
Adverse Events and Potential Risks Lists 
For full details, consult the package insert. 
Table 6-A: Adverse Event List for Vincristine 
Rare or Serious Side Effects 
Frequently Occurring Side Effects 
Autonomic neuropathy 
Nausea and vomiting (minimal) 
Bronchospasm 
Alopecia (reversible) 
Seizure 
Constipation 
Insomnia 
Myelosuppression (mild) 
Cranial Neuropathy 
Musculoskeletal pain  
SIADH 
Peripheral Neuropathy 
Chemical Phlebitis 
 
Acute Hypersensitivity reactions 
 
Hypertension 
 
Table 6-B: Adverse Event List for Bleomycin 
Rare or Serious Side Effects 
Frequently Occurring Side Effects 
Hypotension 
Nausea and vomiting (minimal) 
Pleuropericarditis 
Alopecia (reversible) 
Radiation recall reaction 
Nail changes 
Disseminated intravascular 
coagulation 
Pruritus 
Hemolytic uremic syndrome 
Skin hyperpigmentation 
Pneumonitis 
Mucositis (30%) 
 
Fever, chills 
6.2 
Classification of AEs by Severity and Relationship to Treatment Administration 
6.2.1 Adverse event: Any unfavorable and unintended sign (including an abnormal 
laboratory finding), symptom, or disease temporally associated with the use of a 
medical treatment or procedure regardless of whether it is considered related to the 
medical treatment or procedure (attribution of unrelated, unlikely, possible, 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
27 
NCI Version Date 20MAR2018 
probable, or definite). 
This includes the following: 
• AEs not previously observed in the participant that emerge during the protocol-
specified AE reporting period, including signs or symptoms associated with the 
study disease that were not present prior to study entry. 
• Complications that occur as a result of protocol interventions. 
• Preexisting medical conditions (other than the condition being studied) judged 
by the investigator to have worsened in severity or frequency, or changed in 
character during the protocol-specified AE reporting period. 
AEs will be followed for the participant’s medical care until resolved to the baseline 
condition or protocol completion; for chronic conditions, resolution may occur 
when the AE is stable with appropriate medical management. 
6.2.2 Life-threatening adverse event: Any AE that places the participant or participant, 
in view of the Investigator, at immediate risk of death from the reaction. 
6.2.3 Serious adverse event (SAE): Any AE occurring at any dose that results in any of 
the following outcomes: Death, a life-threatening AE, inpatient hospitalization or 
prolongation of existing hospitalization, a persistent or significant disability/ 
incapacity, or a congenital anomaly/birth defect. Important medical events that may 
not result in death, be life-threatening, or require hospitalization may be considered 
serious when, based upon appropriate medical judgment, they may jeopardize the 
participant and may require medical or surgical intervention to prevent one of the 
outcomes listed in this definition. 
6.2.4 Hospitalization: hospitalization for expedited AE reporting purposes is defined as 
an inpatient hospital stay equal to or greater than 24 hours. Hospitalization is used 
as an indicator of the seriousness of the AE and should ONLY be used for situations 
where the AE truly fits this definition and NOT for hospitalizations associated with 
less serious events. (e.g., a hospital visit where a patient is admitted for observation 
or minor treatment such as, hydration and released in less than 24 hours). 
Prolongation of hospitalization is defined as an extension of current hospitalization 
equal to or greater than 24 hours. 
Please note for hospitalization – All hospitalizations (or prolongation of existing 
hospitalization) for medical events equivalent to CTCAE Grade 3, 4, 5 must be 
reported regardless of the requirements for Phase of study, expected or unexpected, 
and attribution. For example, do not report an admission for pharmacokinetic 
sampling, but do report an admission for a myocardial infarction. 
6.2.5 Toxicity: Toxicity is a term NOT clearly defined by regulatory organizations. 
Toxicity has been described as an AE that has an attribution of possibly, probably 
or definitely related to investigational treatment. To minimize confusion the NCI 
would recommend that the term toxicity NOT be utilized for AE reporting 
purposes. The CTCAE continues to use the term ‘toxicity’ because of familiarity. 
6.2.6 Unexpected adverse event: Any AE that is not listed in available sources including 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
28 
NCI Version Date 20MAR2018 
the package insert, the Investigator’s Brochure, or the protocol, or is not consistent 
with the severity or specificity of the risk information described in the available 
sources, or is not consistent with the severity or specificity of the risk information 
described in the available sources. 
6.2.7 CTEP Adverse Event Reporting System (CTEP-AERS): An electronic system for 
expedited submission of AE reports. A SAE reporting form in Advantage eClinical 
will be used in lieu of CTEP-AERS for expedited AE reporting on this trial. 
6.2.8 Attribution: An assessment of the relationship between the AE and the medical 
intervention. The CTCAE does not define an AE as necessarily “caused by a 
therapeutic intervention.” After naming and grading the event, the clinical 
investigator must assign an attribution to the AE using the following attribution 
categories: 
Table 6-C: Attribution 
RELATIONSHIP 
ATTRIBUTION 
DESCRIPTION 
Unrelated to 
treatment/intervention 
Unrelated 
The AE is clearly NOT related to 
the intervention  
Unlikely 
The AE is doubtfully related to 
the intervention  
Related to 
treatment/intervention 
Possible 
The AE may be related to the 
intervention  
Probable 
The AE is likely related to the 
intervention  
Definite 
The AE is clearly related to the 
intervention  
NOTE: AEs listed as ‘possibly, probably, or definitely’ related to the 
treatment/intervention are considered to have a suspected ‘reasonable causal 
relationship’ to the treatment/intervention (ICH E2A). For routine adverse event 
reporting purposes on this protocol, “attribution” defines the relationship between 
the adverse event and the treatment/intervention. 
6.3 
Expedited Adverse Event Reporting 
6.3.1 Expedited AE reporting for this study must use Advantage eClinical. The reporting 
procedures to be followed are presented in this section and will align with the 
principles for SAE reporting in the “CTEP, NCI Guidelines: Adverse Event 
Reporting Requirements,” which can be downloaded from the CTEP home page 
(http://ctep.cancer.gov). These requirements are briefly outlined below (Section 
6.3.3). 
A 24-hour notification is to be made to the AMC ODMC by telephone at +1 301-
251-1161, only when Internet connectivity is disrupted. Once Internet connectivity 
is restored, a 24-hour notification phoned in must be entered electronically into 
Advantage eClinical by the original submitter at the site. 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
29 
NCI Version Date 20MAR2018 
6.3.2 Advantage eClinical is programmed for automatic electronic distribution of SAE 
reports to the following individuals: the AMC ODMC, AMC Medical Monitor, 
Protocol Chairs, and the Principal Investigator at the institution. 
6.3.3 Expedited reporting guidelines 
Investigators must report ALL SAEs (as defined in Section 6.2.3) that occur from 
enrollment through 30 days following protocol treatment discontinuation to the 
AMC and IRBs as required. The investigator’s initial report to the AMC will be 
made using the Adverse Event form in Advantage eClinical within 24 hours of 
awareness of the event, followed by a completed SAE form within the following 
timelines. 
• Grade 3 SAEs: complete SAE form within 10 calendar days of investigator 
awareness 
• Grade 4 or 5 SAEs: complete SAE form within 5 calendar days of investigator 
awareness 
After 30 days following treatment discontinuation, SAEs will only be reported in 
the SAE form if determined by the investigator to have an attribution to treatment 
of possible, probable, or definite. 
Death due to progressive disease should be reported as Grade 5 “General 
disorders and administration site conditions – Disease Progression.” Evidence 
that the death was a manifestation of underlying disease (e.g., radiological changes 
suggesting tumor growth or progression: clinical deterioration associated with a 
disease process) should be submitted. 
6.3.4 Expedited reporting for pregnancy 
Female participants who become pregnant or initiate breastfeeding while on 
protocol treatment must immediately discontinue protocol treatment. Participants 
will continue to be followed for the remainder of the study visit schedule and 
procedures. AMC-S007 will not provide perinatal care for women. Women who 
become pregnant will be referred to local clinics and/or other research studies for 
prenatal and postpartum care. 
Pregnancy reporting and outcomes will be documented by completion of the 
appropriate CRFs, including the Adverse Event form, using the appropriate term in 
the system organ class (SOC) for Pregnancy, puerperium and perinatal conditions. 
6.3.5 Expedited reporting to regulatory authorities 
The principal investigator is responsible for ensuring that any AE or SAE that 
requires reporting to its IRB or respective national regulatory authority is completed 
in accordance with legal and regulatory timelines. 
As this trial will not be conducted in the U.S., and will not support a marketing 
application or change in labeling or advertising for the drug, the trial is exempt from 
the requirement for an IND. No serious adverse event reporting to FDA is required. 
6.4 
Routine Adverse Event Reporting 
With the exception of the cases noted below, selected adverse events that occur within 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
30 
NCI Version Date 20MAR2018 
timeframes defined in protocol Section 6.4.3 must be reported in routine study data 
submissions. 
6.4.1 Additional protocol-specific routine adverse event reporting exclusions 
All grade 1 adverse events are not required to be reported in the Adverse Event 
Form in Advantage eClinical. These adverse events must be recorded in the source 
documents only. 
6.4.2 Timeline for routine adverse event reporting 
AEs will be recorded in the source and assessed for routine reporting requirements 
from receipt of the first dose of BV through the treatment discontinuation 
evaluation. Following treatment discontinuation, only SAEs that are possibly, 
probably, or definitely attributed to treatment, or grade 5 SAEs will be reported in 
the AE form. 
6.5 
Secondary Malignancy 
A secondary malignancy is a cancer caused by treatment for a previous malignancy (e.g., 
treatment with an agent/intervention, radiation, or chemotherapy). A secondary 
malignancy is not considered a metastasis of the initial neoplasm. 
All secondary malignancies that occur following treatment with standard treatment on this 
protocol will be reported expeditiously via Advantage eClinical. Three options are 
available to describe the event: 
• Leukemia secondary to oncology chemotherapy (e.g., acute myelocytic leukemia 
[AML]) 
• Myelodysplastic syndrome (MDS) 
• Treatment-related secondary malignancy 
Any malignancy possibly related to cancer treatment (including AML/MDS) should also 
be reported via the routine reporting mechanisms outlined in each protocol. 
6.6 
Second Malignancy 
A second malignancy is one unrelated to the treatment of a prior malignancy (and is NOT 
a metastasis from the initial malignancy). Second malignancies require ONLY routine 
adverse event reporting. 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
31 
NCI Version Date 20MAR2018 
7.0 
PHARMACEUTICAL INFORMATION 
No medications will be provided by the study. The site will source medications from its 
usual commercial pharmacy per institutional policy, and administer these drugs in 
accordance with the approved package inserts. 
7.1 
Study Product Preparation 
7.1.1 Bleomycin 
Description 
Bleomycin is an antibiotic complex produced by fermentation from Streptomyces 
verticillus. It causes single- and double-strand DNA breaks through formation of 
an intermediate iron complex. DNA synthesis, and to a lesser degree, RNA and 
protein synthesis are inhibited. Bleomycin is cell cycle phase-specific. Please refer 
to the approved package insert for complete prescribing and toxicity information. 
Reconstitution of Lyophilized Product 
The locally-available formulations of bleomycin are packaged as 15 units of 
bleomycin sulphate powder per vial. Instructions for reconstitution described for 
the Zuvius Lifescience product should be followed: Zuvius’s formulation of 
bleomycin is packaged as 15 units of bleomycin sulphate powder per vial. Using 
aseptic technique, reconstitute each vial with 5 mL of 0.9% sodium chloride for 
injection to yield 3 Units/mL (15 Units/ 5 mL) solution. If these reconstitution and 
preparation instructions are not in accordance with the package insert of the locally-
sourced bleomycin, then the site should must the package insert and proposed 
preparation instructions to the protocol team for review and approval prior to use. 
Withdraw study participant’s calculated dose of bleomycin in mL from the 
reconstituted bleomycin vial(s) into a syringe and inject it into a 50 mL 0.9% 
sodium chloride for injection IV bag. 
Administer the prepared bleomycin in 50 mL 0.9% sodium chloride for injection 
IV bag by IV infusion over 10 minutes. 
Bleomycin prepared in 50 mL 0.9% sodium chloride IV bag for infusion should be 
stored as directed by the manufacturer in the package insert. 
Do not use if a precipitate, foreign matter, or discoloration is present. 
Bleomycin for injection should not be reconstituted or diluted with 5% dextrose for 
injection or other dextrose-containing diluents, as loss of potency can occur. 
Do not mix bleomycin with other drugs or solutions, as compatibility is unknown. 
Caution should be exercised in handling bleomycin. The use of gloves and gown is 
recommended. If bleomycin comes in contact with the skin or mucosa, immediately 
wash thoroughly with soap and water. 
Administration 
Reconstitute with 5-10mL normal saline. 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
32 
NCI Version Date 20MAR2018 
May be given by direct IV push over 10 minutes, followed by a saline flush, if no 
IV line has been set up. Or may further dilute in 100mL normal saline and infuse 
over 10-15 minutes. 
7.1.2 Vincristine sulfate 
Description 
Vincristine sulfate is a vinca alkaloid from the plant Cantharanthus roseus. It acts 
by binding to or crystallizing microtubular proteins of the mitotic spindle. It is a 
cell cycle phase -specific drug and can also affect DNA directed RNA polymerase. 
It has a triphasic half-life and primary elimination is by the liver into the bile and 
feces. Please refer to the approved package insert for complete prescribing and 
toxicity information. 
Drug Preparation and Administration 
Using aseptic technique, withdraw 2 mL from vial(s) of vincristine containing 
2mg/2mL (or 1mg/1mL) into a syringe and cap. 
Vincristine prepared in a syringe should be administered as soon as prepared. 
Do not use if a precipitate, foreign matter or discoloration is present. 
Caution should be exercised in handling vincristine. The use of gloves and gown is 
recommended. If vincristine comes in contact with the skin or mucosa, immediately 
wash thoroughly with soap and water. 
Do not mix vincristine with other drugs or solutions, as compatibility is unknown. 
Include on the prepared vincristine study product label “FATAL IF GIVEN 
INTRATHECALLY. FOR INTRAVENOUS USE ONLY.” 
Administer IV over 1 minute (see Section 4.1 for note regarding acceptable IV 
infusion times). 
Vincristine must be administered via an intact free-flowing intravenous needle or 
into the tubing of a running intravenous infusion and then flushed with the IV fluid 
being administered. Care should be taken that no leakage or swelling occurs during 
administration. If any leakage or swelling occurs during administration, the 
injection should be discontinued immediately and any remaining portion of the dose 
should then be introduced into another vein. 
Vincristine should be administered before bleomycin if given in the same IV line. 
7.1.3 Handling and disposal 
Bleomycin should not be mixed with other drugs until specific compatibility data 
are available. The presence of any bacteriostatic agent, such as benzyl alcohol, may 
cause precipitation of bleomycin and vincristine. 
Caution should be exercised in handling bleomycin and vincristine solutions. The 
use of gloves is recommended. If bleomycin or vincristine comes into contact with 
skin or mucosa, immediately wash thoroughly with soap and water. 
Bleomycin and vincristine should be handled and disposed of in a manner 
consistent with other anti-cancer drugs. 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
33 
NCI Version Date 20MAR2018 
7.2 
Drug Accountability 
Drug accountability will be managed according to local policy. 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
34 
NCI Version Date 20MAR2018 
8.0 
CLINICAL AND LABORATORY EVALUATIONS  
Schedules shown in the Study Calendar below are provided in Appendix I. 
8.1 
Screening/Baseline Evaluations 
Baseline evaluations are to be conducted within 1 week prior to start of protocol therapy, 
unless otherwise specified below. Scans and X-rays must be done within two weeks prior 
to the start of therapy.  
8.1.1 Medical history 
8.1.2 Medication history, including current ART and prior ART regimens in last year. 
Additional dietary supplements, over-the-counter (OTC) medications or traditional 
medications taken within the previous 3 months should also be recorded. 
8.1.3 Physical examination including vitals, height, weight, and performance status 
8.1.4 Pre-treatment staging evaluation includes chest X-ray 
8.1.5 Complete blood cell counts with differentials and platelets, and serum liver/renal 
function analysis. This should include the following: total and direct bilirubin, 
creatinine, SGOT [AST], SGPT [ALT]. 
8.1.6 Oxygen saturation levels (within 14 days before study enrollment) 
8.1.7 Biopsy diagnostic of KS at any time prior to study enrollment 
8.1.8 Tumor measurements 
8.1.9 Serum or urine pregnancy test for women of childbearing potential 
8.2 
Evaluations during Treatment 
Other clinical or laboratory evaluations will be performed as deemed necessary by the 
medical provider. In the event that the participant’s condition is deteriorating, laboratory 
evaluations should be repeated within 24 hours prior to initiation of the next cycle of 
therapy. All evaluations may be performed up to 48 hours prior to scheduled treatment 
unless otherwise stated. 
8.2.1 Toxicity evaluation at every visit. Physical examination with vitals and 
performance status to be performed at every visit, with weight captured at cycles 3 
and 5. 
8.2.2 Complete blood cell counts with differentials and platelets, and serum liver/renal 
function analysis will be required at each pretreatment visit, up to three days prior 
to receiving chemotherapy. See the list of required tests in Section 8.1.5. 
8.2.3 Serum or urine pregnancy test for women of childbearing potential will be 
completed prior to each cycle. 
8.2.4 Oxygen saturation levels will be required at each pretreatment visit, up to three days 
prior to receiving chemotherapy. 
8.2.5 Objective tumor response, toxicity, and clinical benefits will be assessed every 3 
weeks, up to three days prior to initiating next chemotherapy cycle. 
8.2.6 Trained site personnel will administer the quality of life questionnaire (FACT-G, 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
35 
NCI Version Date 20MAR2018 
Appendix IV) at 4 time points: prior to initiating treatment, cycle 4 prior to 
chemotherapy, completion of treatment and final study visit. Results recorded on 
the CRFs. Trained site personnel are defined as site pharmacist, nursing staff, 
clinician, or other trained clinical personnel (e.g., adherence counselors, social 
workers). It is estimated that this assessment will take 10-15 minutes to complete. 
8.3 
Treatment Discontinuation Evaluations 
8.3.1 All participants will have the following evaluations and laboratory tests within three 
weeks of the last dose of protocol treatment, regardless of the reason for 
discontinuation: 
• Physical examination including vitals, weight, and performance status 
• Toxicity evaluation 
• 
Tumor response evaluation, including radiologic evaluation for participants that 
had visceral KS at baseline or those who have symptoms suggestive of visceral 
KS at treatment discontinuation 
• CBC with differentials and platelets 
• Liver and renal function labs as defined in Section 8.1.5 
• Oxygen saturation level 
• FACT-G questionnaire 
8.4 
Final Evaluations, Off Study 
In addition to the evaluations listed below, the Off-Study Summary Form should be 
completed in Advantage eClinical. 
8.4.1 All participants will have the following evaluations and laboratory tests within three 
months of the last dose of protocol treatment, regardless of the reason for 
discontinuation: 
• Physical examination including vitals, weight, and performance status 
• Toxicity evaluation 
• 
Tumor response evaluation, including radiologic evaluation for participants that 
had visceral KS at baseline or those who have symptoms suggestive of visceral 
KS at treatment discontinuation 
• CBC with differentials and platelets 
• Liver and renal function labs as defined in Section 8.1.5 
• Oxygen saturation level 
• FACT-G questionnaire 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
36 
NCI Version Date 20MAR2018 
9.0 
MEASUREMENT OF EFFECT 
All participants will be evaluated for KS response by physical examination as described in 
the AMC KS Tumor Assessment Manual of Procedures (MOP) within 3 days prior to the 
first day of every cycle. See Appendix I for the KS Tumor Assessment schedule. 
9.1 
Definition of Response 
Response and progression will be evaluated in this study as follows: 
9.1.1 Complete response (CR): CR is defined as the absence of any detectable residual 
disease, including tumor-associated edema, persisting for at least 4 weeks. In some 
individuals, residual skin color changes may remain visible at one or more site(s) 
of lesions that were previously raised and/or red or violaceous. Suspected CR in 
those lesions refers only to residual macules (flat, non-palpable lesions) that are 
slightly darker than the surrounding normal skin. If such lesions are present in a 
participant otherwise believed to have a CR, biopsy of at least one such lesion is 
required in order to document the absence of malignant cells and to confirm CR. In 
the event that such a confirmatory biopsy is not performed and residual pigment 
persists, the response will be considered partial (PR). In participants in whom all 
detectable cutaneous disease has resolved and in whom there are no visible 
pigmented macules as described above, a confirmatory skin biopsy is not required. 
In participants known to have had visceral disease, an attempt at restaging with 
appropriate endoscopic or radiographic procedures should be made. 
NOTE: To classify a response as a CR, the participant must have a CR in both the 
cutaneous and noncutaneous (if applicable) sites of disease and no evidence of 
progression as defined by the above criteria. 
9.1.2 Partial response (PR): PR is defined as no new oral lesions or new or progressive 
visceral sites of involvement, or the appearance or worsening of tumor-associated 
edema (as defined in the MOP) or effusions or the development of five or more 
new cutaneous lesions in anatomic sites which were previously documented as 
having no evidence of cutaneous disease; AND 
• A 50% or greater decrease in the number of all lesions present at entry (either 
total body or in the representative areas) lasting for at least 4 weeks; OR 
• Complete flattening of at least 50% of all previously raised lesions (i.e., 50% of 
all nodular or plaque-like lesions become macules, either total body or in the 
representative areas) present at entry lasting for at least 4 weeks; OR 
• A 50% or greater decrease in the area of the cutaneous marker lesions compared 
with entry lasting for at least 4 weeks; OR 
• A 50% or greater decrease in the number or size of all measurable oral or 
visceral lesions lasting for at least 4 weeks, without evidence for progression of 
cutaneous lesions; OR 
• Complete disappearance of non-measurable oral or visceral lesions lasting for 
at least 4 weeks, without evidence for progression of cutaneous lesions. 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
37 
NCI Version Date 20MAR2018 
NOTE: To classify a response as PR, the participant must have at least a PR in 
either the cutaneous or noncutaneous sites of disease, and no evidence of 
progression as defined in the above criteria. 
NOTE: Participants with residual tumor-associated edema or effusion who 
otherwise meet the criteria for CR will be classified as having a PR. 
9.1.3 Stable disease (SD) is defined as any response not meeting the criteria for CR, PR, 
or progressive disease. 
9.1.4 Progressive disease (PD) is defined as follows: 
For participants with ≤50 cutaneous lesions 
PD is defined as any one or more of the following: 
• ≥ 25% increase in the area of the cutaneous marker lesions compared to entry 
or best response; 
• ≥ 25% increase in the total lesion count, or a minimum of five new lesions, 
whichever is greater, compared with entry or best response; 
• ≥ 25% increase in the number of raised lesions, or a minimum of five new raised 
lesions, whichever is greater, compared with entry or best response. 
NOTE: There are body sites where disease is particularly difficult to evaluate, and 
a few new lesions may be counted in spite of the fact that a participant is not actually 
progressing. For example, lesions of the foot, particularly those that are flat, are 
difficult to evaluate because their intensity may vary based on how much edema is 
present, how much the person walked the day before, how long his/her feet have 
been in a dependent position prior to the physical exam. 
For participants with >50 cutaneous lesions 
PD is defined as any one or more of the following: 
• ≥ 25% increase in the area of the cutaneous marker lesions compared to entry 
or best response; 
• ≥ 25% increase in the total number of lesions in the prospectively defined 
anatomic sites containing representative lesions; 
• a total of five new lesions in anatomic sites that were previously documented 
as having no evidence of cutaneous disease, 
• ≥ 25% increase in the number of raised lesions in the prospectively defined 
anatomic sites containing representative lesions (minimum of five raised 
lesions if there are very few raised lesions, for example < 8) whichever is 
greater. Photographic documentation of “gross” or significant progression, 
particularly in areas that were not being followed, will be of particular value. 
9.1.5 Noncutaneous progression (PD): Noncutaneous PD includes new oral or visceral 
sites of involvement or progression of oral or visceral disease or the development 
of new or increasing tumor-associated edema or effusion that interferes with the 
participant’s normal activities lasting for at least two consecutive evaluations. 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
38 
NCI Version Date 20MAR2018 
Progressive oral or visceral disease, for measurable and evaluable disease, should 
be analogous to cutaneous KS response criteria. 
Progressive edema is defined as the following: 
• An increase in non-pitting/woody edema in an upper or lower extremity 
associated with an increase in limb circumference of at least 3 cm from entry or 
best response, sustained for at least two consecutive evaluations, and measured 
at a fixed point on the extremity with respect to a bony landmark (e.g., 10 cm 
below the lower border of the patella); AND/OR 
• New appearance of non-pitting/woody edema in an extremity where none was 
previously present, sustained for at least two consecutive evaluations; AND/OR 
• New or worsening edema in a non-extremity site (e.g., periorbital, genital) that 
interferes with function and is sustained for at least two consecutive 
evaluations. 
9.1.6 Recurrent disease 
Recurrent disease is defined as the appearance of tumor following documentation 
of a complete remission. 
9.1.7 Time to response 
Time to response is defined as time from the first dose of chemotherapy until 
documentation of first response. 
9.1.8 Time to progression 
Time to progression is defined as time from initiation of chemotherapy to 
documentation of first progression. 
9.1.9 Response duration 
Response duration is defined as the time from first documentation of response to 
documentation of first progression. 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
39 
NCI Version Date 20MAR2018 
10.0 
STATISTICAL CONSIDERATIONS 
10.1 
Study Design/Endpoints 
This is a prospective observational study to evaluate the quality of life of patients receiving 
liposomal doxorubicin for HIV-associated Kaposi sarcoma and a single institution in 
Tanzania. The exploratory aim of this trial is to assess clinical data collection quality for 
site evaluation and training purposes only. 
All patients presenting for care of HIV-associated KS at Bugando Medical Centre during 
a 1-year study period will be approached for enrollment. 
10.2 
Sample Size/Accrual Rate 
We anticipate approximately 1-2 participant will be accrued each month, for a total of 
approximately 12 to 20 participants. 
10.3 
Statistical Analysis 
We expect 1-2 participants per month during a 1-year enrollment for a total of 12-20 
participants. With limited enrollment, statistics are exploratory only. QOL questionnaires 
will be collected prior to treatment, after 3 cycles, at treatment completion and 3 months 
after treatment completion. The four domains of the FACT-G questionnaire will be 
determined for each questionnaire: physical well-being, social/family well-being, 
emotional well-being and functional well-being. Using general estimating equations, we 
will explore changes in these domains with time. Logistic regression analyses will be used 
to correlate changes in quality of life domains with clinical response. 
 
 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
40 
NCI Version Date 20MAR2018 
11.0 
ROLE OF DATA MANAGEMENT 
11.1 
CRF Instructions 
Access to the internet data entry system for this study, Advantage eClinical, and 
instructions for recording of study data on CRFs will be provided by the AMC ODMC at 
www.amcoperations.com. Participating institutions are responsible for submitting data 
and/or data forms via Advantage eClinical in accordance with the AMC Data Entry Guide 
and specific form instructions, within the timelines specified by the AMC’s Standards of 
Procedure for Site Performance Measures. 
11.2 
Data Quality 
It is the responsibility of the AMC ODMC to assure the quality of data for the study (See 
Appendix III, AMC Data and Safety Monitoring Plan). This role extends from protocol 
development to generation of the final study database. 
11.3 
Data Monitoring 
This study will be monitored in compliance with AMC policies and by the Clinical Data 
Update System (CDUS) Version 3.0. Cumulative protocol- and participant-specific CDUS 
data will be submitted electronically to CTEP on a quarterly basis. Reports are due January 
31, April 30, July 31, and October 31. Instructions for submitting data using the CDUS can 
be found on the CTEP Web site (http://ctep.cancer.gov/reporting/cdus.html). The AMC 
ODMC is responsible for compiling and submitting CDUS data to CTEP for all participants 
and for providing the data to the Principal Investigator for review. 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
41 
NCI Version Date 20MAR2018 
12.0 
ETHICAL AND REGULATORY CONSIDERATIONS 
12.1 
IRB Approval and Informed Consent 
The principles of Institutional Review Board (IRB) approval and informed consent 
described in the Department of Health and Human Services (DHHS) regulations for the 
Protection of Human Subjects regulations (45 CFR Part 46) must be followed. IRB 
approval of the protocol and the informed consent form must be given in writing. 
The sponsor’s designee (AMC ODMC) must receive a copy of the letter of approval from 
the IRB/IEC, which specifically approves the protocol and informed consent, before 
participant enrollment. The IRB/IEC must also approve any significant changes to the 
protocol and documentation of this approval must be sent to the AMC ODMC. The IRB 
must review the research project at least once every 365 days during the duration of the 
project. Continuing approval of the project must also be given in writing and provided to 
the AMC ODMC. 
Records of all study review and approval documents must be kept on file by the 
Investigator and are participant to inspection during or after completion of the study. AEs 
must be reported to the IRB according to local procedures. The IRB should receive 
notification of completion of the study and final report within 3 months of study completion 
and termination. The Investigator will maintain an accurate and complete record of all 
submissions made to the IRB, including a list of all reports and documents submitted. 
Written informed consent will be obtained from the participant. The nature, significance 
and risks associated with the study must be explained to the participant. The informed 
consent will describe the purpose of the study, the procedures to be followed, the risks and 
benefits of participation, all risks of study participation as listed in the model informed 
consent form, and all other elements of informed consent as required by regulation. A copy 
of the consent form will be given to the participant to keep. 
In addition, any institution(s) conducting research according to the guidelines of this 
protocol is required to adhere to local and national laws and regulations governing the 
confidentiality and disclosure of health information. 
12.2 
Changes to the Protocol 
Any change or addition to this protocol requires a written protocol amendment that must 
be approved by CTEP and the Investigator before implementation. All amendments require 
approval by the IRB/IEC of the treating institution. A copy of the written approval of the 
IRB/IEC and NIMR must be sent to the ODMC. 
12.3 
Women and Minorities 
This study is being conducted by the NCI-sponsored AIDS Malignancy Consortium 
(AMC). As part of their contractual obligations, each participating site within the AMC 
and the AMC as a whole is required to assure that the participation of women and minority 
participants reflects the percentage representation of these populations in their geographic 
region. As such, it is expected that the representation of participants on this trial will reflect 
the constitution of the respective populations. 
 
 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
42 
NCI Version Date 20MAR2018 
Table 12-A: Accrual Targets 
INTERNATIONAL PLANNED ENROLLMENT REPORT 
Racial Categories 
Ethnic Categories 
Total 
Not Hispanic or Latino 
Hispanic or Latino 
Female 
Male 
Female 
Male 
American 
Indian/ 
Alaska Native 
0 
0 
0 
0 
0 
Asian 
0 
0 
0 
0 
0 
Native Hawaiian or 
Other 
Pacific 
Islander 
0 
0 
0 
0 
0 
Black or African 
American 
10 
10 
0 
0 
20 
White 
0 
0 
0 
0 
0 
More 
Than 
One 
Race 
0 
0 
0 
0 
0 
Total 
10 
10 
0 
0 
20 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
43 
NCI Version Date 20MAR2018 
13.0 
REFERENCES 
1. Ganem D. KSHV infection and the pathogenesis of Kaposi's sarcoma. Ann Rev Pathol 
2006;1:273-96. 
2. Stewart S, Jablonowski H, Goebel FD, et al: Randomized comparative trial of pegylated 
liposomal doxorubicin versus bleomycin and vincristine in the treatment of AIDS-related 
Kaposi's sarcoma. International Pegylated Liposomal Doxorubicin Study Group. J Clin 
Oncol 16:683-91, 1998 
3. Gill PS, Miles SA, Mitsuyasu RT, et al: Phase I AIDS Clinical Trials Group (075) study of 
adriamycin, bleomycin and vincristine chemotherapy with zidovudine in the treatment of 
AIDS-related Kaposi's sarcoma. AIDS 8:1695-9, 1994 
4. Northfelt DW, Dezube BJ, Thommes JA, et al: Pegylated-liposomal doxorubicin versus 
doxorubicin, bleomycin, and vincristine in the treatment of AIDS-related Kaposi's 
sarcoma: results of a randomized phase III clinical trial. J Clin Oncol 16:2445-51, 1998 
5. Welles L, Saville MW, Lietzau J, et al. Phase II trial with dose titration of paclitaxel for the 
therapy of human immunodeficiency virus-associated Kaposi's sarcoma. J Clin Oncol 
1998;16:1112-21. 
6. Tulpule A, Groopman J, Saville MW, et al. Multicenter trial of low-dose paclitaxel in patients 
with advanced AIDS-related Kaposi sarcoma. Cancer 2002; 95:147-154. 
7. Stebbing J, Wildfire A, Portsmouth S, et al. Paclitaxel for anthracycline-resistant AIDS-related 
Kaposi's sarcoma: clinical and angiogenic correlations. Ann Oncol 2003; 14:1660-1666. 
8. Cianfrocca M, Lee S, Von Roenn J, et al. Randomized trial of paclitaxel versus pegylated 
liposomal doxorubicin for advanced human immunodeficiency virus-associated Kaposi’s 
sarcoma: 
Evidence 
for 
symptom 
palliation 
from 
chemotherapy. 
Cancer 
2010;116(16):3969-77. 
9. Tanzania Commission for AIDS (TACAIDS), Zanzibar AIDS Commission (ZAC), National 
Bureau of Statistics (NBS), Office of the Chief Government Statistician (OCGS), and ICF 
International 2013. Tanzania HIV/AIDS and Malaria Indicator Survey 2011-12. Dar es 
Salaam, Tanzania: TACAIDS, ZAC, NBS, OCGS, and ICF International. 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
 
 
 
 
44 
NCI Version Date 20MAR2018 
APPENDIX I: SCHEDULE OF EVALUATIONS 
The schedule of evaluations below applies to all participants on study. Baseline laboratory evaluations are to be conducted within one 
week before starting of therapy. Scans and x-rays must be done within two weeks prior to the start of therapy. If the participant’s 
condition is deteriorating, laboratory evaluations should be repeated within 24 hours before initiation of the next cycle of therapy. 
 
Pre-
Study 
Cycle 
1 
Cycle 
2 
Cycle 
3 
Cycle 
4 
Cycle 
5 
Cycle 
6 
Treatment 
Discontinuation 
Off 
Study 
Informed consent 
X 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
 
 
 
Physical exam 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Vital signs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Height 
X 
 
 
 
 
 
 
 
 
Weight 
X 
 
 
X 
 
X 
 
X 
X 
Biopsy diagnostic of KS (fixed in formalin) 
Xe 
 
 
 
 
 
 
 
 
FACT-G Questionnaire 
 
Xf 
 
 
X 
 
 
X 
X 
Toxicity evaluations 
 
X 
X 
X 
X 
X 
X 
X 
X 
Performance status 
X 
X 
X 
X 
X 
X 
X 
X 
X 
CBC w/diff, plts 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Serum chemistrya 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Oxygen saturation 
Xb 
X 
X 
X 
X 
X 
X 
X 
X 
Radiologic evaluation 
X 
 
 
 
 
 
 
X 
X 
Tumor measurements 
X 
 
X 
 
X 
 
X 
X 
X 
Pregnancy testc 
Xd 
 
X 
X 
X 
X 
X 
 
 
a: 
Total and direct bilirubin, creatinine, SGOT [AST], SGPT [ALT]. 
b. 
Within 14 days before enrollment 
c. Prior to chemotherapy. 
d: 
Serum pregnancy test (women of childbearing potential). 
e. 
A skin biopsy of an area of KS will be done prior to treatment start if one has not already been done in the past. 
f: 
Prior to initiating treatment. 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
45 
NCI Version Date 20MAR2018 
APPENDIX II: PERFORMANCE STATUS SCALES 
 
Karnofsky Performance Scale 
ECOG Performance Status Scale 
Percent 
Description 
Grade 
Description 
100 
Normal, no complaints, no 
evidence of disease. 
0 
Normal activity. Fully active, able to 
carry on all pre-disease performance 
without restriction. 
90 
Able to carry on normal activity; 
minor signs or symptoms of 
disease. 
80 
Normal activity with effort; some 
signs or symptoms of disease. 
1 
Symptoms, but ambulatory. 
Restricted in physically strenuous 
activity, but ambulatory and able to 
carry out work of a light or 
sedentary nature (e.g., light 
housework, office work). 
70 
Cares for self, unable to carry on 
normal activity or to do active 
work. 
60 
Requires occasional assistance, 
but is able to care for most of 
his/her needs. 
2 
In bed <50% of the time. 
Ambulatory and capable of all self-
care, but unable to carry out any 
work activities. Up and about more 
than 50% of waking hours. 
50 
Requires considerable assistance 
and frequent medical care. 
40 
Disabled, requires special care and 
assistance. 
3 
In bed >50% of the time. Capable of 
only limited self-care, confined to 
bed or chair more than 50% of 
waking hours. 
30 
Severely disabled, hospitalization 
indicated. Death not imminent. 
20 
Very sick, hospitalization 
indicated. Death not imminent. 
4 
100% bedridden. Completely 
disabled. Cannot carry on any self-
care. Totally confined to bed or 
chair. 
10 
Moribund, fatal processes 
progressing rapidly. 
0 
Dead. 
5 
Dead. 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
46 
NCI Version Date 20MAR2018 
APPENDIX III: AMC DATA AND SAFETY MONITORING PLAN 
(Version 6.0  March 17, 2017) 
 
Monitoring the Progress of Trials and the Safety of Participants 
All AMC protocols that collect safety data follow the National Cancer Institute (NCI), Cancer 
Therapy Evaluation Program (CTEP) Guidelines: Adverse Event Reporting Requirements 
(http://ctep.cancer.gov/guidelines/index.html). All adverse events that meet the NCI’s expedited 
reporting requirements are reported to the Investigational Drug Branch (IDB) of the NCI via the 
CTEP Adverse Event Reporting System (CTEP-AERS) web application. All expedited adverse 
event reports are also required to be submitted to the local Institutional Review Board (IRB) of the 
reporting institution. If NCI holds the IND or no IND is required for a study, the AMC site reports 
serious adverse events directly to the AMC Operations and Data Management Center (ODMC) via 
CTEP-AERS; expedited reporting via AdvantageEDC/Advantage eClinical may be permitted for 
select commercial agent studies per protocol requirements. In some instances, the AMC sites may 
report serious adverse events directly to a commercial sponsor holding the IND, who will then 
report the event to the AMC ODMC. Most AMC protocols require sites to report all serious 
adverse events via CTEP-AERS and the AMC ODMC to forward a copy of the report to the 
sponsor. The AMC ODMC also distributes all IND safety reports to all investigators upon receipt, 
and makes these reports available on the password-protected section of the AMC Operations web 
site. Unless an AMC protocol specifies an alternate plan for the review and submission of serious 
adverse events, all serious adverse events received by the AMC ODMC will be reviewed by the 
AMC Medical Monitor at the AMC ODMC. For protocols for which the IDB does not have an 
assigned drug monitor to review serious adverse event reports, in the event of disagreement 
between the reporting physician and the AMC Medical Monitor regarding the attribution of the 
event to the investigational agent(s) (i.e., determination of whether the relationship is unrelated, 
unlikely, possible, probable, or definite), the AMC Medical Monitor will provide the final 
determination of the relationship. 
The AMC ODMC provides listings of all reported adverse events and serious adverse events to 
the Protocol Chair and Co-chair(s) for review on a regular basis. The AMC ODMC compiles these 
events in a tabular format and posts them on the password-protected section of the AMC web site 
where these reports are updated nightly. The AMC web site is accessible to all AMC investigators, 
co-investigators, and their staff. Email notification that this information is available on the web 
site will be sent to all site PIs. It is the responsibility of each site to provide this information to 
their respective IRBs, if required by their IRB. For blinded studies, the serious adverse events are 
reviewed and tabulated without treatment assignment. The AMC Medical Monitor will review 
listings of all reported adverse events on a quarterly basis for safety concerns. 
Accrual summaries for each AMC trial are updated nightly on the password-protected section of 
the AMC web site. The progress of each AMC trial is reviewed regularly by the Protocol Chair 
and also by the appropriate disease-oriented Working Group during scheduled conference calls. 
For phase I dose escalation trials, dose escalation (or dose de-escalation) is based on the rules in 
the protocol and the Protocol Chair, AMC Medical Monitor, and Group Statistician determine 
whether these criteria have been met. For phase II trials, stopping the trial for toxicity or efficacy, 
or suspending enrollment pending observation of responses in a multi-stage phase II trial, is based 
on meeting criteria stated in the protocol, and the Protocol Chair, AMC Medical Monitor, and 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
47 
NCI Version Date 20MAR2018 
Group Statistician determine whether these criteria have been met. 
For phase III trials and other select studies requiring additional oversight, the AMC has formed an 
independent Data and Safety Monitoring Board (DSMB). Voting members of the DSMB are 
physicians, a statistician, and a patient advocate. All voting members are from outside the AMC. 
Nonvoting members are the AMC Group Statistician, the protocol statistician, an AMC Operations 
Center staff member, two representatives (normally a clinician or statistician) from the Office of 
HIV AIDS Malignancy (OHAM) or from the Cancer Therapy Evaluation Program, Division of 
Cancer Treatment and Diagnosis, of the National Cancer Institute (NCI). The DSMB reviews 
AMC phase III studies in accordance with the National Cancer Institute’s Policy for Data and 
Safety Monitoring. Confidential reports of all phase III trials are prepared by the AMC Group 
Statistician with support from the AMC ODMC. A written report containing the current status of 
each trial monitored, and when appropriate, any toxicity and outcome data, are sent to DSMB 
members by the AMC ODMC within the timelines specified by the DSMB Charter. This report 
addresses specific toxicity concerns as well as concerns about the conduct of the trial. The report 
may contain recommendations for consideration by the DSMB concerning whether to close the 
trial, report the results, or continue accrual or follow-up. 
The results of each DSMB meeting are summarized in a formal report sent by the DSMB Chair to 
the Group Chair and AMC ODMC. The DSMB report contains recommendations on whether to 
close each study reviewed, whether to report the results, and whether to continue accrual or follow-
up. A primary recommendation (e.g., continue with no change; recommended or required 
modification; stop) must be included in the document. The Group Chair is then responsible for 
notifying the Protocol Chair and relevant Disease-oriented Working Group Chair before the 
recommendations of the DSMB are carried out. In the unlikely event that the Protocol Chair does 
not concur with the DSMB, then the NCI Division Director or designee must be informed of the 
reason for the disagreement. The Study Chair, relevant Disease-oriented Working Group Chair, 
Group Chair, DSMB Chair, and NCI Division Director or designee will be responsible for reaching 
a mutually acceptable decision about the study. CTEP approval of a formal amendment will be 
required prior to any implementation of a change to the study. 
Following a DSMB meeting, a summary of the serious adverse events reported to the DSMB is 
posted to the AMC web site. It is each site’s responsibility for conveying this information to its 
IRB. 
Plans for Assuring Compliance with Requirements Regarding the Reporting of Adverse 
Events (AE) 
For trials monitored by the NCI’s Clinical Data Update System (CDUS), adverse event 
information is transmitted electronically to NCI on a quarterly basis. For trials monitored by NCI’s 
Clinical Trials Monitoring Service (CTMS), adverse event information is transmitted 
electronically to NCI every two weeks. 
The Protocol Chair, AMC Group Chair, and the AMC ODMC share responsibility in assuring that 
participating investigators comply with the protocol requirements for adverse event reporting. All 
AMC investigators certify compliance with NCI and FDA requirements for adverse event 
reporting by signing the AMC Adherence Statement for site membership, the protocol signature 
page for each protocol active at the site, and Form FDA-1572 for CTEP investigator registration 
and IND studies sponsored by AMC investigators. Investigators are responsible for identifying 
and reporting all adverse events to the AMC ODMC, CTEP-AERS, and/or sponsors according to 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
48 
NCI Version Date 20MAR2018 
the protocol requirements, and assuring compliance with reporting to the local IRB. Protocol 
compliance with adverse event reporting requirements is assessed by the AMC ODMC during 
routine site audits by reviewing the site’s source documentation.  
The data entry system used for AMC studies, AdvantageEDC/Advantage eClinical (a web-based 
data entry and enrollment system), is programmed to notify the site investigator, protocol chair, 
AMC Medical Monitor, and AMC ODMC via email in the event that a site reports an adverse 
event that meets expedited reporting criteria to NCI and/or FDA. If the site does not follow with 
an expedited report, the AMC ODMC contacts sites to request compliance with reporting 
requirements. Additionally, the protocol chair, AMC ODMC, and the AMC Medical Monitor 
review reported adverse events on a routine basis to identify adverse events reported by sites that 
require expedited reporting. The Protocol Chair, AMC Group Chair, and IND sponsors have 
general oversight for assuring that routine and expedited adverse reporting requirements are met 
by the responsible parties. 
Plans for Assuring that any Action Resulting in a Temporary or Permanent Suspension of 
an NCI-Funded Clinical Trial is Reported to the NCI Grant Program Director Responsible 
for the Grant 
In the event that termination of the trial or major modification to the protocol is under 
consideration, the Protocol Chair will convene the AMC Data Coordinator and Disease-oriented 
Working Group Chair by conference call to discuss the options. For phase I and II trials, the 
Protocol Chair also has the option of asking the DSMB to review the study. The AMC ODMC will 
inform the CTEP Protocol Information Office (PIO) when studies are temporarily or permanently 
closed. The Cancer Treatment and Evaluation Program (CTEP) of the National Cancer Institute 
(NCI) must approve all protocol amendments prior to distributing to the AMC sites. 
Plans for Assuring Data Accuracy and Protocol Compliance 
All study data for AMC clinical trials are entered directly by AMC clinical site staff into 
AdvantageEDC/Advantage eClinical. During data entry, the system performs validation checks on 
many fields and performs consistency checks between select fields. Range checks are placed on 
each field to eliminate entry of out-of-range values. Edit check programs are run on the database 
on a set schedule to identify and resolve inconsistencies between forms or data collected at 
different points in time. AMC ODMC staff routinely interacts with site staff to resolve any data 
problems. 
In accordance with NCI guidelines, the AMC ODMC conducts audits at the AMC sites to evaluate 
compliance with regulatory issues, and to review data for specific cases by checking source 
documents. These reports are sent to the site Principal Investigator and to the NCI. In the event 
that major violations are identified, sites are asked to provide a written corrective and preventative 
action plan to correct deficiencies. If needed, a repeat site audit is conducted. In the event that a 
site does not correct deficiencies in a pre-determined time frame, the AMC Executive Committee 
has the option of taking action against the site. Possible actions include, but are not limited to, 
suspending enrollment of new patients to AMC trials until deficiencies are corrected; 
recommending a decrease in funding to the site; and requiring specific training for site 
investigators or staff members. 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
49 
NCI Version Date 20MAR2018 
APPENDIX IV: FACT-G QUESTIONNAIRE, VERSION 4, ENGLISH AND SWAHILI 
Below is a list of statements that other people with your illness have said are important. Please 
circle or mark one number per line to indicate your response as it applies to the past 7 days. 
 
PHYSICAL WELL-BEING 
Not at all 
A little 
bit 
Some-
what 
Quite 
a bit 
Very 
much 
GP1 
I have a lack of energy………………….. 
0 
1 
2 
3 
4 
GP2 
I have nausea……………………………. 
0 
1 
2 
3 
4 
GP3 
Because of my physical condition, I have 
trouble meeting the needs of my family… 
 
0 
 
1 
 
2 
 
3 
 
4 
GP4 
I have 
pain……………………………………… 
0 
1 
2 
3 
4 
GP5 
I am bothered by side effects of treatment 
0 
1 
2 
3 
4 
GP6 
I feel ill………………………………….. 
0 
1 
2 
3 
4 
GP7 
I am forced to spend time in bed………... 
0 
1 
2 
3 
4 
 
SOCIAL/FAMILY 
WELL-
BEING 
Not at all 
A little 
bit 
Some-
what 
Quite 
a bit 
Very 
much 
 
GS1 
I feel close to my friends………………… 
0 
1 
2 
3 
4 
GS2 
I get emotional support from my family…. 
0 
1 
2 
3 
4 
GS3 
I get support from my friends……………. 
0 
1 
2 
3 
4 
GS4 
My family has accepted my illness……… 
0 
1 
2 
3 
4 
GS5 
I am satisfied with family communication 
about my illness…………………………. 
 
0 
 
1 
 
2 
 
3 
 
4 
GS6 
I feel close to my partner (or the person 
who is my main support)………………… 
 
0 
 
1 
 
2 
 
3 
 
4 
Q1 
Regardless of your current level of sexual 
activity, please answer the following question. 
If you prefer not to answer it, please mark this 
box      and go to the next section. 
 
 
 
 
 
GS7 
I am satisfied with my sex life…………… 
0 
1 
2 
3 
4 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
50 
NCI Version Date 20MAR2018 
Please circle or mark one number per line to indicate your response as it applies to 
the past 7 days. 
 
EMOTIONAL WELL-BEING 
Not at 
all 
A little 
bit 
Some-
what 
Quite 
a bit 
Very 
much 
GE1 
I feel sad………………………………… 
0 
1 
2 
3 
4 
GE2 
I am satisfied with how I am coping with 
my illness………………………………… 
0 
1 
2 
3 
4 
GE3 
I am losing hope in the fight against my 
illness…………………………………….. 
0 
1 
2 
3 
4 
GE4 
I feel nervous……………………………... 
0 
1 
2 
3 
4 
GE5 
I worry about dying………………………. 
0 
1 
2 
3 
4 
GE6 
I worry that my condition will get 
worse……………………………………...
0 
1 
2 
3 
4 
 
 
FUNCTIONAL WELL-BEING 
 
Not at 
all 
A little 
bit 
Some-
what 
Quite 
a bit 
Very 
much 
GF1 
I am able to work (include work at home)…. 
0 
1 
2 
3 
4 
GF2 
My work (include work at home) is fulfilling 
0 
1 
2 
3 
4 
GF3 
I am able to enjoy life……………………… 
0 
1 
2 
3 
4 
GF4 
I have accepted my illness…………………. 
0 
1 
2 
3 
4 
GF5 
I am sleeping well………………………… 
0 
1 
2 
3 
4 
GF6 
I am enjoying the things I usually do for fun 
0 
1 
2 
3 
4 
GF7 
I am content with the quality of my life right 
now………………………………………... 
0 
1 
2 
3 
4 
 
 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
51 
NCI Version Date 20MAR2018 
FACT-G (Version 4), SWAHILI 
Hapa chini kuna orodha ya kauli ambazo watu wengine wenye ugonjwa wako wamesema 
ni muhimu. Tafadhali chagua nambari moja katika kila mstari na kuichorea duara ili 
kuonyesha kadiri kila kauli ilivyokuwa na ukweli kwako wakati wa siku 7 zilizopita. 
 
 
HALI YA KIMWILI 
 
Hata 
kidogo 
Kidogo 
Wastani 
Zaidi ya 
wastani 
Sana 
 
 
 
 
GP1 
Nina upungufu wa nguvu.............. 
 
0 
1 
2 
3 
4 
 
GP2 
Nina kichefuchefu………………. 
 
0 
1 
2 
3 
4 
 
GP3 
Kutokana na hali yangu ya 
kimwili nina matatizo ya kukidhi 
mahitaji ya familia yangu……….. 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
GP4 
Nina maumivu............................... 
 
0 
1 
2 
3 
4 
 
GP5 
Ninasumbuliwa na athari mbaya 
za matibabu……………………… 
 
0 
1 
2 
3 
4 
 
GP6 
Ninajisikia mgonjwa...................... 
 
0 
1 
2 
3 
4 
 
GP7 
Ninalazimika kukaa kitandani…... 
 
0 
1 
2 
3 
4 
 
 
HALI YA 
JAMII/FAMILIA 
 
Hata 
kidogo 
Kidogo 
Wastani 
Zaidi ya 
wastani 
Sana 
 
 
 
 
GS1 
Najisikia karibu na marafiki 
zangu……………………………. 
 
0 
1 
2 
3 
4 
 
GS2 
Ninapata msaada moyoni kutoka 
kwa familia yangu………………. 
 
0 
1 
2 
3 
4 
 
GS3 
Ninapata msaada kutoka kwa 
rafiki zangu……………………… 
 
0 
1 
2 
3 
4 
 
GS4 
Familia yangu imeukubali 
ugonjwa wangu.............................. 
 
0 
1 
2 
3 
4 
 
GS5 
Nimeridhika na mawasiliano ya 
familia yangu kuhusu ugonjwa 
wangu............................................ 
 
 
0 
 
1 
 
2 
 
3 
 
4 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
52 
NCI Version Date 20MAR2018 
 
 
Hata 
kidogo 
Kidogo 
Wastani 
Zaidi ya 
wastani 
Sana 
 
GS6 
Ninajisikia karibu na mwenzangu 
(au mtu anayenisaidia zaidi)......... 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
Q1 
 
 
 
 
 
 
GS7 
Bila kujali kiwango chako cha sasa katika tendo la 
kujamiana, tafadhali jibu maswali yafuatayo. Kama 
hupendelei kujibu maswali haya tafadhali weka 
alama kwenye kisanduka hiki        na kisha nenda 
kwenye sehemu inayofuata 
 
 
 
 
Nimeridhika na hali yangu ya 
unyumba…………………………
0 
1 
2 
3 
4 
 
 
Tafadhali chagua nambari moja katika kila mstari na kuichorea duara ili 
kuonyesha kadiri kila kauli ilivyokuwa na ukweli kwako wakati wa siku 7 zilizopita. 
 
 
HALI YA JAZIBA 
 
Hata 
kidogo 
Kidogo 
Wastani 
Zaidi ya 
wastani 
Sana 
 
 
 
 
GE1 
Nina huzuni………………………. 
 
0 
1 
2 
3 
4 
 
GE2 
Nimeridhika na jinsi ninavyokabili 
ugonjwa wangu…………………... 
 
0 
1 
2 
3 
4 
 
GE3 
Nimeanza kukata tamaa 
kupambana na ugonjwa wangu…... 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
GE4 
Nina wasiwasi……………………. 
 
0 
1 
2 
3 
4 
 
GE5 
Ninahofu kuhusu kifo……………. 
 
0 
1 
2 
3 
4 
 
GE6 
Nina wasiwasi kwamba hali yangu 
itazidi kuwa mbaya......................... 
 
0 
 
1 
 
2 
 
3 
 
4 
 
 
 

AMC-S007 (Version 2.0) 20MAR2018 
 
 
53 
NCI Version Date 20MAR2018 
 
HALI YA UTENDAJI  
Hata 
kidogo 
Kidogo 
Wastani 
Zaidi ya 
wastani 
Sana 
 
 
 
 
GF1 
Ninaweza kufanya kazi (pamoja na 
zile za nyumbani)………………… 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
GF2 
Kazi yangu (pamoja na kazi 
ninayoifanya nyumbani) 
inaridhisha....................................... 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
GF3 
Ninaweza kufurahia maisha............ 
 
0 
1 
2 
3 
4 
 
GF4 
Nimekubali hali ya ugonjwa 
wangu.............................................. 
 
0 
1 
2 
3 
4 
 
GF5 
Ninalala vizuri…………………… 
 
0 
1 
2 
3 
4 
 
GF6 
Nayafurahia mambo ninayofanya 
kujifurahisha……………………... 
 
0 
1 
2 
3 
4 
 
GF7 
Nimeridhika na hali ya maisha hivi 
sasa………………………………..
0 
1 
2 
3 
4