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| Version Date: February 6, 2014   |                                                                                                                                                                  |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Table of Contents                |                                                                                                                                                                  |
| 1                                | INTRODUCTION .                                                                                                                                                   |
| 1.1                              | Study Objectives:                                                                                                                                                |
| 1.2                              | Background and Rationale: .................................................................................................................................... 8 |
| 1.2.1                            | Carcinoma of the Anal Canal.                                                                                                                                     |
| 1.2.2                            | Rationale For Inclusion Of Patients With HIV-Infection .............................................. 9                                                          |
| 1.2.3                            | Preclinical Data With MTS-01 .......................................................................................................... 10                       |
| 1.2.4                            | Clinical Experience With MTS-01 ............................................................................................... 12                               |
| 1.2.5                            | Summary of Rationale .                                                                                                                                           |
| 1.2.6                            | Rationale For Translational Endpoints ............................................................................................ 14                            |
| 2                                | ELIGIBILITY ASSESSMENT AND ENROLLMENT.                                                                                                                           |
| 2.1                              | Eligibility Criteria                                                                                                                                             |
| 2.1.1                            | Inclusion Criteria .                                                                                                                                             |
| 2.1.2                            | Exclusion Criteria .                                                                                                                                             |
| 2.2                              | Screening Evaluation                                                                                                                                             |
| 2.2.1                            | Clinical Evaluation.                                                                                                                                             |
| 2.2.2                            | Laboratory Evaluation                                                                                                                                            |
| 2.2.3                            | Radiographic Evaluation.                                                                                                                                         |
| 2.2.4                            | Baseline Evaluation of Primary Tumor and surrounding Mucosa............................ 16                                                                       |
| 2.2.5                            | Pathologic Review                                                                                                                                                |
| 2.3                              | Registration Procedures                                                                                                                                          |
| 3                                | STUDY IMPLEMENTATION .                                                                                                                                           |
| Study Design:                    |                                                                                                                                                                  |
| 3.1                              |                                                                                                                                                                  |
| 3.2                              | Study Drug Administration                                                                                                                                        |
| 3.2.1                            | MTS-01 .                                                                                                                                                         |
| 3.2.2                            | 5-Fluoruracil (5-FU) and Mitomycin C ................................................................................. 19                                        |
| 3.3                              | Dose Modification for Toxicities:                                                                                                                                |
| 3.3.1                            | Modification of MTS-01 .                                                                                                                                         |
| 3.3.2                            | Modifications in 5-Fluorouracil                                                                                                                                  |
| 3.3.3                            | Discontinuation of Mitomycin C .                                                                                                                                 |
| 3.3.4                            | Dose Delays                                                                                                                                                      |
| 3.4                              | Correlative Studies for Research/Pharmacokinetic Studies: ............................................ 20                                                        |
| 3.4.1                            | PBMC Sampling                                                                                                                                                    |
| 3.4.2                            | Evaluation of Persistent HIV Viremia During Therapy (HIV+ only) ................... 21                                                                           |
| 3.4.3                            | Optional Anal Cancer Biopsy (Patient need not be HIV+) ........................................... 21                                                            |
| 3.4.4                            | Optional Anal Cancer Cytology (Patient need not be HIV+) ....................................... 22                                                              |
| 3.4.5                            | Optional Rectal Mucosal Snag Biopsies (Patient need not be HIV+) .................... 23                                                                         |
| 3.5                              | Study Calendar:                                                                                                                                                  |
| 3.6                              | Concurrent Therapies:                                                                                                                                            |
| 3.6.1                            | Chemotherapy-Induced Nausea and Vomiting Prophylaxis ............................................ 25                                                             |
| 3.6.2                            | Anti-retroviral Therapy                                                                                                                                          |
| 3.6.3                            | Pneumocystis jiroveci Prophylaxis                                                                                                                                |
| 3.6.4                            | MMAC Prophylaxis .                                                                                                                                               |
| 3.6.5                            | Topical agents .                                                                                                                                                 |
| 3.7                              | Surgical Guidelines: .                                                                                                                                           |
| 3.8                              | Radiation Therapy Guidelines:                                                                                                                                    |  
Amendment D  
| Version Date: February 6, 2014                                                                                  |                                                                                                                                              |                 |
|-----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| 3.8.1                                                                                                           | Simulation .                                                                                                                                 |                 |
| 3.8.2                                                                                                           | T Treatment volumes                                                                                                                          |                 |
| 3.8.3                                                                                                           | T Treatment Planning                                                                                                                         |                 |
| T Treatment delivery .                                                                                          |                                                                                                                                              |                 |
| 3.8.4                                                                                                           |                                                                                                                                              |                 |
| 3.8.5                                                                                                           | Treatment breaks                                                                                                                             |                 |
| 3.9                                                                                                             | Criteria for Removal from Protocol Therapy and Off Study Criteria .......................... 28                                              |                 |
| Criteria for removal from protocol therapy (NOTE:  chemotherapy and                                             |                                                                                                                                              |                 |
| 3.9.1                                                                                                           |                                                                                                                                              |                 |
| radiotherapy will continue as tolerated):                                                                       |                                                                                                                                              |                 |
| 3.9.2                                                                                                           | Off-study Criteria                                                                                                                           |                 |
| SUPPORTIVE CARE                                                                                                 |                                                                                                                                              |                 |
| 4                                                                                                               | 4.1                                                                                                                                          | Pain Control    |
| 4.2                                                                                                             | D Diarrhea .                                                                                                                                 |                 |
| 4.3                                                                                                             | Opportunistic infections .                                                                                                                   |                 |
| 4.4                                                                                                             | Anemia .                                                                                                                                     |                 |
| 4.5                                                                                                             | Thrombocytopenia                                                                                                                             |                 |
| 4.6                                                                                                             | Neutropenia and Neutropenic Fever.                                                                                                           |                 |
| 5                                                                                                               | DATA COLLECTION AND EVALUATION                                                                                                               |                 |
| 5.1                                                                                                             | Data Collection, Patient Confidentiality and Data Disclosure ............................................ 29                                 |                 |
| 5.2                                                                                                             | Response Criteria                                                                                                                            |                 |
| 5.2.1                                                                                                           | Antitumor Effect - Solid Tumors                                                                                                              |                 |
| 5.2.2                                                                                                           | Definitions                                                                                                                                  |                 |
| 5.2.3                                                                                                           | Disease Parameters .                                                                                                                         |                 |
| 5.2.4                                                                                                           | Methods for Evaluation of Measurable Disease .................................................................... 32                         |                 |
| 5.2.5                                                                                                           | Response Criteria                                                                                                                            |                 |
| 5.3                                                                                                             | Toxicity Criteria                                                                                                                            |                 |
| 5.3.1                                                                                                           | CE v4.0                                                                                                                                      |                 |
| 5.3.2                                                                                                           | RTOG Morbidity Scoring Schema ........................................................................................................... 37 |                 |
| 5.3.3                                                                                                           | Photography of treatment area                                                                                                                |                 |
| Sample Storage, Tracking, and Disposition                                                                       |                                                                                                                                              |                 |
| 5.4                                                                                                             |                                                                                                                                              |                 |
| 5.4.1                                                                                                           | AIDS Monitoring Laboratory .                                                                                                                 |                 |
| 5.4.2                                                                                                           | Tracking Samples                                                                                                                             |                 |
| 5.4.3                                                                                                           | Samples for Planned Collaborations                                                                                                           |                 |
| 5.4.4                                                                                                           | Routine Samples                                                                                                                              |                 |
| 5.4.5                                                                                                           | Unused, Lost or Destroyed Samples ............................................................................................. 39           |                 |
| 6                                                                                                               | STATSTICAL SECTION                                                                                                                           |                 |
| 7                                                                                                               | HUMAN SUBJECTS PROTECTIONS .                                                                                                                 |                 |
| 7.1                                                                                                             | Rationale for Subject Selection: .                                                                                                           |                 |
| 7.2                                                                                                             | Participation of Children: .                                                                                                                 |                 |
| 7.3                                                                                                             | Evaluation of Benefits and Risks/Discomforts: .................................................................. 41                          |                 |
| 7.4                                                                                                             | Risks/Benefits Analysis:                                                                                                                     |                 |
| Consent and Assent Process and Documentation: .............................................................. 42 |                                                                                                                                              |                 |
| 7.5                                                                                                             |                                                                                                                                              |                 |
| SAFETY REPORTING REQUIREMENTS/DATA AND SAFETY MONITORING PLAN                                                   |                                                                                                                                              |                 |
| 8                                                                                                               | 42                                                                                                                                           | Definitions     |
| 8.1                                                                                                             | 8.1.1                                                                                                                                        | A Adverse Event |
| 8.1.2                                                                                                           | Suspected adverse reaction .                                                                                                                 |                 |  
Amendment D  
| Version Date: February 6, 2014                                                                                               |                                                                                                                           |
|------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| 8.1.3                                                                                                                        | Unexpected adverse reaction                                                                                               |
| 8.1.4                                                                                                                        | Serious                                                                                                                   |
| 8.1.5                                                                                                                        | Serious Adverse Event                                                                                                     |
| Disability                                                                                                                   |                                                                                                                           |
| 8.1.6                                                                                                                        |                                                                                                                           |
| 8.1.7                                                                                                                        | Life-threatening adverse drug experience.                                                                                 |
| 8.1.8                                                                                                                        | Protocol Deviation (NIH Definition)                                                                                       |
| 8.1.9                                                                                                                        | Non-compliance (NIH Definition)                                                                                           |
| 8.1.10                                                                                                                       | Unanticipated Problem                                                                                                     |
| 8.2                                                                                                                          | NCI-IRB Adverse Event Reporting                                                                                           |
| NCI-IRB Expedited Reporting of Unanticipated Problems, and Deaths............... 44                                          |                                                                                                                           |
| 8.2.1                                                                                                                        |                                                                                                                           |
| 8.2.2                                                                                                                        | NCI-IRB Requirements for PI Reporting at Continuing Review ............................ 45                                |
| 8.2.3                                                                                                                        | NCI IRB Reporting of IND Safety Reports............................................................................... 46 |
| IND Sponsor Reporting Criteria                                                                                               |                                                                                                                           |
| 8.3                                                                                                                          |                                                                                                                           |
| 8.4                                                                                                                          | FDA Reporting Criteria (Refer to 21 CFR 312.32)                                                                           |
| 8.4.1                                                                                                                        | IND Safety Reports to the FDA (Refer to 21 CFR 312.32) ............................................ 46                    |
| 8.4.2                                                                                                                        | FDA Annual Reports (Refer to 21 CFR 312.33) ............................................................... 47            |
| 8.4.3                                                                                                                        | Expedited Adverse Event Reporting Criteria to the IND Manufacturer............... 47                                      |
| 8.5                                                                                                                          | DATA AND SAFETY MONITORING Plan                                                                                           |
| Principal Investigator/Research Team .................................................................................... 47 |                                                                                                                           |
| 8.5.1                                                                                                                        |                                                                                                                           |
| 8.5.2                                                                                                                        | Sponsor Monitoring Plan                                                                                                   |
| 9                                                                                                                            | PHARMCEUTICAL AND INVESTIGATIONAL DEVICE INFORMATION ............... 48                                                   |
| 9.1                                                                                                                          | MTS-01 .                                                                                                                  |
| Source:  Mitos, IND 112272                                                                                                   |                                                                                                                           |
| 9.1.1                                                                                                                        |                                                                                                                           |
| 9.1.2                                                                                                                        | T TOXICITY                                                                                                                |
| 9.1.3                                                                                                                        | Formulation and preparation                                                                                               |
| 9.1.4                                                                                                                        | Stability and storage                                                                                                     |
| 9.1.5                                                                                                                        | Administration procedures                                                                                                 |
| 9.1.6                                                                                                                        | Incompatibilities                                                                                                         |
| 9.2                                                                                                                          | 5-Fluorouracil .                                                                                                          |
| 9.2.1                                                                                                                        | SOURCE .                                                                                                                  |
| 9.2.2                                                                                                                        | Pharmacology .                                                                                                            |
| 9.2.3                                                                                                                        | T TOXICITY                                                                                                                |
| 9.2.4                                                                                                                        | Formulation and preparation                                                                                               |
| 9.2.5                                                                                                                        | Stability and storage                                                                                                     |
| 9.2.6                                                                                                                        | Administration procedures                                                                                                 |
| 9.2.7                                                                                                                        | Incompatibilities                                                                                                         |
| 9.3                                                                                                                          | Mitomycin C.                                                                                                              |
| SOURCE                                                                                                                       |                                                                                                                           |
| 9.3.1                                                                                                                        |                                                                                                                           |
| 9.3.2                                                                                                                        | Pharmacology .                                                                                                            |
| 9.3.3                                                                                                                        | TOXICITY                                                                                                                  |
| 9.3.4                                                                                                                        | Formulation and preparation                                                                                               |
| 9.3.5                                                                                                                        | Stability and storage                                                                                                     |
| 9.3.6                                                                                                                        | Administration procedures                                                                                                 |
| Incompatibilities                                                                                                            |                                                                                                                           |
| 9.3.7                                                                                                                        |                                                                                                                           |
| REFERENCES .                                                                                                                 |                                                                                                                           |
| 10                                                                                                                           |                                                                                                                           |
| l l                                                                                                                          | Appendices                                                                                                                |  
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appendix iv brief pain inventory

Date:
Name:
Time:
1) Throughout our lives, most of us have had pain from time to time (such as minor headaches, sprains, and toothaches). Have you had pain other than these everyday kinds of pain today?  
1. Yes 2. No 2) On the diagram, shade in the areas where you feel pain. Put an X on the area that hurts the most.  
  
3) Please rate your pain by circling the one number that best describes your pain at its worst in the past 24 hours.  
00 1 2 31 4 51 46 17 81 9 10 No Pain as bad as you con imagine pabr 4) Please rate your pain by circling the one number that best describes your pain at its least in the last 24 hours.  
00 NO
Pain as bad as you can imagine pain 5) Please rate your pain by circling the one number that best describes your pain on average.  
10 11 12 131 14 151 16 171 181 9 10 NO
Pain as bad as pavi you con imaginal 6) Please rate your pain by circling the one number that tells how much pain you have right now.  
00 1 12 131 141 151 16 17 181 19 10 Pain as bad as No you can imagine L Appetite 8) In the past 24 hours, how much relief have pain treatments or medications provided? Please circle the one percentage that most shows how much relief you have received.  
0% 10 20 30 40 50 60 70 80 90 100%
Complete NO
rass rs ar 9) Circle the one number that describes how, during the past 24 hours, pain has interfered with your:
A. General activity 00 Does not Completely ine the relati interferes B. Mood 0 1 2 3 4 5 6 7 8 9 10 Dow not issentere COMPLICATION
interferes C. Walking ability 00 11 2, 33445566778899 10 Doos not interfere D. Normal work (includes both work outside the home and housework).  
000    2003   4.15    6007   8009010 Does not ite rfere E. Relations with other people
(0) 1 2 2 3 4 5 6 7 8 9 10 Doo not 00 Completely interferes Complish interferes F. Sleep 2, 3, 4, 5, 6, 7, 8, 9, 10 0 1 Does not iterfere G. Enjoyment of life to 011 21 31 41 35 61 71 81 92 10 DOS NOT
vis perc H. Ability to concentrate 10 11 2 3 4 5 6 7 8 9 10 DAS NO
illeriere interfords Complains)
Completely interferes Complexed interferes pavi 7) What treatments or medications are you receiving for your pain?  
viser/ere  
00 1112223344555666778899910
Does not  
  
  
interferes
May be duplicated for use in clinical matters in McCaffey M, Pastro C: Pain: Clinical manual, p. 61, 1999, Mody, Inc. From oc with the Centers for Medicare and Medicaid Services (CMS). The contents presented do not necessarily reflect CMS policy.  
Augus 2001 Completely interferes
untitled h1
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-0,1 Since some genetic variations can help to predict the future health problems of the patient and the patient's relatives, this information might be of interest to employers, health providers, insurance companies, and others. Patterns of genetic variation also can be used by law enforcement agencies to identify a person or his/her relatives. Therefore, the patient genetic information potentially could be used in ways that could cause the patient or his/her family distress, such as by revealing that the patient (or a relative) carries a genetic disease or by leading to the denial of employment or insurance for the patient (or a relative).  
There also may be other privacy risks that we have not foreseen.  While we believe that the risks to the patient and his/her family are very low, we are unable to tell exactly what all of the risks are. There are some state laws that protect against genetic discrimination by employers or insurance companies, but there is no federal law yet that prohibits such discrimination. We believe that the benefits of learning more about cancer and other diseases outweigh these potential risks.
untitled h1
confidentiality v.8

We will make every attempt to protect the patient's confidentiality and to make sure that the patient's personal identity does not become known. The signed consent form will be stored in a locked file that will be accessible only to a very small number of authorized people involved in this project. We will carefully follow the coding, storage, and release plan explained in the Description of the Research section on pages 1-3 of this document.  
To help us protect the confidentiality of the patient's information, we have obtained a Certificate of Confidentiality from the National Institutes of Health.  With this Certificate, we cannot be forced to disclose information that may identify the patient, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings. We will use this Certificate to resist any demands for information that would identify the patient, with the following exceptions:
.  
.  
The Certificate cannot be used to resist a request for the patient information from the United States Government when the information is to be used for auditing or evaluation of federally funded projects or for information that must be disclosed to meet the requirements of the federal Food and Drug Administration (FDA). The Certificate does not prevent the patient or a member of patient's family from voluntarily releasing information about the patient or patient's involvement in this research. Also, if the patient have given written consent to an insurer, employer, or other person to receive research information, then we may not use the Certificate to withhold that information.
untitled h1
v.9 project results

Scientists at the Genome Sciences Center at the British Columbia Cancer Agency will upload data into the project database using coded samples, and will not report findings to study participants.  The Principal Investigator or Lead Associate Investigator from this study will review reported genetic mutations within 3 months from the time they are entered into the project database.  Individual results from this research project will generally not be given back to the patient or put into the patient's medical records. However, if a germline mutation that  
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