Clinical trial NCT03641326
Conditions: Gliosarcoma Central Nervous System Sarcoma
Keywords: Gliosarcoma Brain Tumor MDASI
Sponsor: National Cancer Institute (NCI)
Start date: 2019-02-21; Completion date: 2021-04-02
Enrollment: 5 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Background:

A sarcoma is a rare cancer. It grows in the body's connective tissue. Sarcomas in the brain and central nervous system are especially rare. The drug Sunitinib has been approved in many countries for treating other types of rare or advanced cancers. These include kidney, pancreas, and bowel cancer. Researchers want to see if it can help people with sarcomas of the central nervous system.

Objective:

To study the effects of Sunitinib on gliosarcomas or sarcomas of the central nervous system.

Eligibility:

Adults ages 18 and older with a gliosarcoma or sarcoma of the central nervous system

Design:

Participants will be screened with the following tests. Some may be done as part of their regular cancer care:

Medical history

Medication review

Physical exam

Blood, heart, and pregnancy tests

Cranial scans to locate and measure their tumor

Participants will take Sunitinib by mouth every day for 2 weeks and then take none of the drug for 1 week. These 3 weeks equal 1 cycle.

Participants will have 2 study visits in cycle 1. They will have 1 visit in all other cycles. They will answer questions about quality of life and repeat some screening tests.

Participants will take their blood pressure at home weekly. They keep a diary of each dose of Sunitinib and blood pressure reading.

Participants can choose to share data about their physical activity levels and quality of sleep. These participants will wear a small, portable watch-sized accelerometer device on the wrist for 6 cycles.

About 1 month after their last study drug dose, participants will have a final study visit. They will have a physical exam, blood tests, and scans.

Detailed description:
Background:

* Gliosarcoma and primary central nervous system (CNS) sarcomas are malignant brain tumors uniformly associated with poor outcome.
* There are no known effective medical therapies for these cancers.
* Sunitinib is an orally administered small molecule that inhibits signaling of multiple receptor tyrosine kinases including those known to be activated in CNS sarcomas.

Objectives:

To determine the anti-tumor effect of sunitinib in recurrent gliosarcomas and primary CNS sarcomas as assessed by objective response rate (ORR).

Eligibility:

* Patients with histologically proven gliosarcoma and primary CNS sarcoma at disease relapse after failing standard therapy (surgery and irradiation).
* Tumor tissue blocks or 15 unstained slides should be available
* Subjects must be greater than or equal to 18 years old.
* Karnofsky performance status of greater than or equal to 60
* Patients must have adequate organ function.
* Patients must not have received tyrosine kinase inhibitor(s) in the past.

Design:

* This is a prospective, single institution, single arm, multi-cohort phase II study of sunitinib in subjects with recurrent gliosarcoma and primary CNS sarcoma that have failed prior surgery and irradiation (unless radiation therapy was contraindicated).
* Subjects will be classified into three cohorts: 1) Primary gliosarcoma; 2) Secondary gliosarcoma; 3) Primary CNS sarcoma. Cohort expansion will be carried out at indication of promising response.
* Sunitinib will be administered orally using a continuous schedule at 50 mg per day (with dose adjustments allowed for toxicity) for 2 weeks with 1 week off to constitute a 3-week cycle until disease progression or development of intolerable side-effects.
* Toxicity will be assessed every cycle by Common Terminology Criteria in Solid Tumors (CTCAE) version 5.0.

Arms: arm 1: Sunitinib will be administered at a dose of 50 mg daily for 2 consecutive weeks followed by 1 week of rest. Participants will be given a small, portable pager-type and watch accelerometers to wear at the hip or non-dominant wrist. Worn daily for 6 cycles arm 2: Sunitinib will be administered at a dose of 50 mg daily for 2 consecutive weeks followed by 1 week of rest. Participants will be given a small, portable pager-type and watch accelerometers to wear at the hip or non-dominant wrist. Worn daily for 6 cycles arm 3: Sunitinib will be administered at a dose of 50 mg daily for 2 consecutive weeks followed by 1 week of rest. Participants will be given a small, portable pager-type and watch accelerometers to wear at the hip or non-dominant wrist. Worn daily for 6 cycles
Interventions: intervention 1: Sunitinib intervention 2: wGT3x-BT
Intervention descriptions: intervention 1: Sunitinib will be administered at a dose of 50 mg daily for 2 consecutive weeks followed by 1 week of rest until there is disease progression or development of intolerable side effects. intervention 2: Participants will given a small, portable pager-type and watch accelerometers to wear at the hip or non-dominant wrist. Worn daily for 6 cycles

Protocol documents:
ICF_001.pdf: 
MEDICAL RECORD 
CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY 
• 
Adult Patient or 
• Parent, for Minor Patient 
INSTITUTE: 
National Cancer Institute 
STUDY NUMBER: 
18-C-0137 
PRINCIPAL INVESTIGATOR:  
Mark Gilbert, MD 
STUDY TITLE:  
Phase II Study of Sunitinib in Sarcomas of the Central Nervous System 
Continuing Review Approved by the IRB on 06/16/20 
 
Amendment Approved by the IRB on 06/22/20 (B) 
      Date posted to web:  06/24/20 
Standard 
PATIENT IDENTIFICATION 
CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY 
• Adult Patient or 
• Parent, for Minor Patient 
NIH-2514-1 (07-09) 
P.A.:  09-25-0099 
File in Section 4:  Protocol Consent (1) 
 
 
INTRODUCTION 
We invite you to take part in a research study at the National Institutes of Health (NIH). 
First, we want you to know that: 
Taking part in NIH research is entirely voluntary.  
You may choose not to take part, or you may withdraw from the study at any time.  In 
either case, you will not lose any benefits to which you are otherwise entitled.  However, 
to receive care at the NIH, you must be taking part in a study or be under evaluation for 
study participation. 
You may receive no benefit from taking part.  The research may give us knowledge that 
may help people in the future. 
Second, some people have personal, religious or ethical beliefs that may limit the kinds of 
medical or research treatments they would want to receive (such as blood transfusions).  If you 
have such beliefs, please discuss them with your NIH doctors or research team before you agree 
to the study. 
Now we will describe this research study.  Before you decide to take part, please take as much 
time as you need to ask any questions and discuss this study with anyone at NIH, or with family, 
friends or your personal physician or other health professional.   
Why is this study being done?  
The purpose of this study is to find out what effects, good and/or bad, the drug sunitinib malate 
(referred to as sunitinib) will have on you and your gliosarcoma or sarcoma of the central 


MEDICAL RECORD 
CONTINUATION SHEET for either: 
NIH 2514-1, Consent to Participate in A Clinical Research Study 
NIH 2514-2, Minor Patient’s Assent to Participate In A Clinical Research 
Study 
STUDY NUMBER:     18-C-0137 
CONTINUATION: page 2 of 16 pages 
 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
NIH-2514-1 (07-09) 
NIH-2514-2 (10-84) 
P.A.:  09-25-0099 
File in Section 4:  Protocol Consent 
 
nervous system. Sunitinib has been approved in many countries for treating other types of rare or 
advanced cancers such as kidney, pancreas, stomach and bowel cancer but it is experimental in 
the treatment of your cancer.  
Why are you being asked to take part in this study? 
You are being asked to take part in this study because you have been diagnosed with a rare 
cancer (gliosarcoma or central nervous system (CNS) sarcoma) which is eligible for this 
treatment.  
How many people will take part in this study?  
This study is being conducted at the National Cancer Institute and it will have three groups: 1) 
patients with primary gliosarcoma; 2) patients with secondary gliosarcoma; 3) primary CNS 
sarcoma. Each group will enroll 32 patients for a total of 96 patients. Depending on the results, 
the study may expand to a second stage and enroll more patients.  
Description of Research Study 
This study is being conducted on an outpatient basis. Sunitinib is a pill taken once a day, in the 
morning, with or without food. Sunitinib is stored at room temperature. The dose for this study is 
50 mg of sunitinib daily for two weeks, followed by 1 week off with no sunitinib. This 3-week 
period is called a cycle. During each cycle, you will return to the clinic for certain study-related 
tests (see Study Chart below for details). 
This research study also includes an option to share information about your physical activity 
levels and the quality of your sleep, because tiredness and lack of energy are risks of sunitinib. If 
you agree to this optional study procedure, you will be asked to wear, a small, portable watch-
sized accelerometer device (called an “Actigraph”) on your wrist. The Actigraph device will 
monitor your overall physical activity levels and sleep patterns throughout six cycles of 
treatment.  
What will happen if you take part in this research study? 
Before you begin the study 
Before any study-related procedures are performed, you will be asked to read and sign this 
informed consent form. If you wish to participate, you agree to return to this clinic for all study-
related appointments and tests mentioned below. Additional visits may be required to assess and 
treat side effects. No overnight hospital or clinic stays are required; however, if serious side 
effects occur, overnight hospital stays may be required to treat the side effects. 


MEDICAL RECORD 
CONTINUATION SHEET for either: 
NIH 2514-1, Consent to Participate in A Clinical Research Study 
NIH 2514-2, Minor Patient’s Assent to Participate In A Clinical Research 
Study 
STUDY NUMBER:     18-C-0137 
CONTINUATION: page 3 of 16 pages 
 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
NIH-2514-1 (07-09) 
NIH-2514-2 (10-84) 
P.A.:  09-25-0099 
File in Section 4:  Protocol Consent 
 
You will need to have the following screening exams, tests or procedures to find out if you can 
be in the study. These tests are part of regular cancer care and may be done if you do not join the 
study. If you had some of these recently, you may not need to repeat them. This will be up to 
your study doctor. 
• Complete medical history, physical exam (including neurological exam, height, weight) 
• Monitor blood pressure and vital signs 
• Documentation of all prescription and over-the-counter medications which you are taking 
• Standard blood tests (including blood cell counts and chemistries)  
• Cranial imaging (CT or MRI) to locate and measure your tumor 
• Tissue block and/or unstained slides of the cancer to submit to the study doctor or a 
member of the research team 
• An electrocardiogram (ECG), a recording of the electrical activity of your heart 
• An echocardiogram, an ultrasound study which shows the structure and function of your 
heart 
• Serum pregnancy test, for women of child-bearing potential  
During the study 
During the first three weeks of treatment (cycle 1), you will return to the hospital twice (on days 
1 and 8) for study procedures (see Study Chart below). Afterwards, you will need to return to 
the hospital for a clinic visit with your care team once every three weeks. The purpose of each 
clinic visit will be to monitor your progress on this trial, manage any side effects you may 
experience, and decide if you should continue this treatment.  
While on study, you will take Sunitinib 50 mg by mouth daily for two weeks on (days 1-14) and 
then one week of rest (no Sunitinib on days 15-21). You will pick up your Sunitinib medication 
at the NIH Pharmacy at no cost to you.  
You will also need to take your blood pressure at home weekly while on this study. The study 
team will give you a diary to keep track of each dose of Sunitinib and each blood pressure 
reading. At the end of each cycle, you will bring the completed diary to each clinic visit so you 
can review it with the research team.  
After completing 2 cycles of treatment, you will return to clinic for imaging (MRI or CT scan). 
This test is needed to determine if the treatment is helping to shrink your tumor. Imaging will be 


MEDICAL RECORD 
CONTINUATION SHEET for either: 
NIH 2514-1, Consent to Participate in A Clinical Research Study 
NIH 2514-2, Minor Patient’s Assent to Participate In A Clinical Research 
Study 
STUDY NUMBER:     18-C-0137 
CONTINUATION: page 4 of 16 pages 
 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
NIH-2514-1 (07-09) 
NIH-2514-2 (10-84) 
P.A.:  09-25-0099 
File in Section 4:  Protocol Consent 
 
scheduled every 6 weeks until end of treatment.   At each visit prior to imaging, you will also be 
asked to complete a questionnaire rating your quality of life. This survey takes about 5 minutes 
to complete. 
The treatment cycle may be repeated for as long as you are receiving benefit from the drug (and 
any side effects you experience are bearable). Once you stop getting any benefit from the study 
drug, or the side effects are no longer tolerable, we will stop the treatment. 
When you are finished taking the drugs (treatment) 
Approximately one month after your last dose of Sunitinib, you will return for a final study visit. 
During this clinic visit, you will have a physical exam with a health care provider, blood work 
and imaging (MRI/CT scan). See Study Chart for details. You will be asked to return the 
Actigraph device and any medication diaries to the study team.  


MEDICAL RECORD 
CONTINUATION SHEET for either: 
NIH 2514-1, Consent to Participate in A Clinical Research Study 
NIH 2514-2, Minor Patient’s Assent to Participate In A Clinical Research 
Study 
STUDY NUMBER:     18-C-0137 
CONTINUATION: page 5 of 16 pages 
 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
NIH-2514-1 (07-09) 
NIH-2514-2 (10-84) 
P.A.:  09-25-0099 
File in Section 4:  Protocol Consent 
 
Study Chart 
Day 
What to do and what will happen to you 
Before 
starting study 
• 
Check-in to the Outpatient Clinic 
• 
Complete medical history and physical exam (including neurological 
exam and vital signs) by a Health Care Provider 
• 
Routine blood tests 
• 
Research blood tests 
• 
A baseline cranial MRI/CT scan 
• 
Questionnaire about your quality of life 
During 
treatment 
• 
Clinic visit– monitor vital signs, review medical history and physical 
exam by a Health Care Provider* 
• 
Routine blood tests*  
• 
Research blood tests*  
• 
Begin Sunitinib 50 mg by mouth daily for two weeks (days 1-14) 
• 
Maintain a medication diary every day (days 1-21) 
• 
Monitor your blood pressure at home weekly 
• 
Cranial imaging test (MRI or CT scan) after cycle 2 (and then every 6 
weeks for as long as you receive the study medication) 
• 
Complete a questionnaire about your quality of life 
• 
Replace battery on actigraphy device, optional assessment 
*During Cycle 1, these procedures will occur on day 1 and day 8; all other 
cycles only on day 1 
After 
treatment 
Approximately 30 days after last dose of study drug: 
• 
Clinic visit –physical exam by a Health Care Provider 
• 
Monitor vital signs and weight 
• 
Routine blood tests including thyroid function tests 
• 
Research blood tests 


MEDICAL RECORD 
CONTINUATION SHEET for either: 
NIH 2514-1, Consent to Participate in A Clinical Research Study 
NIH 2514-2, Minor Patient’s Assent to Participate In A Clinical Research 
Study 
STUDY NUMBER:     18-C-0137 
CONTINUATION: page 6 of 16 pages 
 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
NIH-2514-1 (07-09) 
NIH-2514-2 (10-84) 
P.A.:  09-25-0099 
File in Section 4:  Protocol Consent 
 
• 
MRI/CT scan and MDASI survey  
• 
Return Actigraphy device, if applicable 
 
Birth Control 
If you are a woman who is breast feeding or pregnant, you may not take part in the study because 
we don’t know how this medicine would affect your baby or your unborn child. If you are a 
woman who can become pregnant, or are the partner of a woman who can become pregnant, you 
will need to practice an effective form of birth control before starting study treatment, during 
study treatment, and for two months after you finish study treatment.  If you think that you or 
your partner is pregnant, you should tell your study doctor or nurse at once. It is also important to 
note that treatment with sunitinib may make men and women unable to have children in the 
future. 
Effective forms of birth control include:  
• 
abstinence  
•       intrauterine device (IUD) 
• 
hormonal [birth control pills, injections, or implants] 
• 
tubal ligation 
• 
vasectomy 
Risks or Discomforts of Participation 
What side effects or risks can I expect from being in this study?  
Studies have shown high blood pressure to be one common side effect of sunitinib. Your blood 
pressure will be closely watched while you are taking sunitinib. This will include having you 
check your blood pressure at home on a weekly basis for the entire study. If you have high blood 
pressure while taking sunitinib, your study doctor may recommend follow-up with your primary 
care physician and/or starting or increasing medication to lower blood pressure. 
Sunitinib may affect how different parts of your body work, such as your liver, kidneys, heart, 
thyroid and blood. The study doctor will be testing your blood and will let you know if changes 
occur that may affect your health.  


MEDICAL RECORD 
CONTINUATION SHEET for either: 
NIH 2514-1, Consent to Participate in A Clinical Research Study 
NIH 2514-2, Minor Patient’s Assent to Participate In A Clinical Research 
Study 
STUDY NUMBER:     18-C-0137 
CONTINUATION: page 7 of 16 pages 
 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
NIH-2514-1 (07-09) 
NIH-2514-2 (10-84) 
P.A.:  09-25-0099 
File in Section 4:  Protocol Consent 
 
Blood Draws 
Blood draws may cause pain, bleeding, and/or bruising. You may faint and/or develop an 
infection with redness and irritation of the vein at the site where blood is drawn. Frequent blood 
collection may cause anemia (low red blood cell count), which may create a need for blood 
transfusions. 
Questionnaires 
Questionnaires may contain questions that are sensitive in nature. You may refuse to answer any 
question that makes you feel uncomfortable. The primary use of the information you provide is 
to assess the severity of your symptoms. Submission of this information is voluntary. If you have 
concerns about completing the questionnaire, you are encouraged to contact your doctor or the 
Principal Investigator. 
Sunitinib side effects 
There is also a risk that you could have side effects from the study drug/study approach. You can 
make side effects less of a problem by telling the study team if you notice or feel anything 
different so they can see if you are having a side effect. The study doctor may adjust the 
Sunitinib dose to try to reduce the side effects. 
The list below shows the most common and the most serious side effects that researchers know 
about. There might be other side effects that researchers do not yet know about. If important new 
side effects are found, the study doctor will discuss these with you.  
This study may involve unpredictable risks to the participants including death. 
Likely side effects (>10%) seen in people taking sunitinib include the following:  
• 
Feeling tired, lack of energy, dizziness  
• 
Frequent or excessive bowel movements  
• 
Stomach treatment-related symptoms: nausea, vomiting, diarrhea, stomatitis, indigestion, 
decreased appetite, changes in taste (or complete lack of taste) 
• 
Hand and Foot syndrome (redness, pain, swelling or peeling of the palms of the hands or 
soles of the feet) 
• 
High blood pressure requiring medical intervention 
• 
Low Blood Sugar 
• 
Inflammation of the sinuses and nose (mucosal inflammation) 


MEDICAL RECORD 
CONTINUATION SHEET for either: 
NIH 2514-1, Consent to Participate in A Clinical Research Study 
NIH 2514-2, Minor Patient’s Assent to Participate In A Clinical Research 
Study 
STUDY NUMBER:     18-C-0137 
CONTINUATION: page 8 of 16 pages 
 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
NIH-2514-1 (07-09) 
NIH-2514-2 (10-84) 
P.A.:  09-25-0099 
File in Section 4:  Protocol Consent 
 
• 
Low platelet counts that could cause bruising or bleeding 
• 
Low red blood cell count (anemia) that may result in feeling tired or short of breath and may 
require blood transfusion 
• 
Low white blood cell count (neutropenia) that could increase the risk of infection 
• 
Skin and hair changes (skin may become yellow, skin/hair may be lighter) 
• 
Skin changes (dry skin, skin thickening or cracking) 
 
Less likely side effects (<10%) seen in people taking sunitinib include the following:  
• Abnormal liver function 
• 
Inflammation of pancreas that may show up as upper belly pain that may move to the back, 
nausea and vomiting that feels worse when eating 
• Inflammation of the liver that may show up as yellowing of the skin and whites of the eyes, 
fever and belly pain  
• 
Thyroid problems  
• 
Wounds that are slow to heal or do not heal 
• 
Damage to the jawbone which may cause loss of teeth 
• 
Kidney damage which may require dialysis 
• 
Blot clot to lungs which may cause shortness of breath, pain, loss of consciousness  
 
Rare and serious side effects (<1%) seen in people taking sunitinib include the following:  
Please note that some of these events have been previously stated above, so some have occurred 
more frequently but with less severity. 
• 
A tear or hole in the intestines which may require surgery 
• 
Belly pain 
• 
Blot clot to lungs which may cause shortness of breath, pain, loss of consciousness  
• 
Bleeding/bruising 
• 
Bleeding in brain 


MEDICAL RECORD 
CONTINUATION SHEET for either: 
NIH 2514-1, Consent to Participate in A Clinical Research Study 
NIH 2514-2, Minor Patient’s Assent to Participate In A Clinical Research 
Study 
STUDY NUMBER:     18-C-0137 
CONTINUATION: page 9 of 16 pages 
 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
NIH-2514-1 (07-09) 
NIH-2514-2 (10-84) 
P.A.:  09-25-0099 
File in Section 4:  Protocol Consent 
 
• 
Change in heart rhythm  
• 
Diarrhea  
• 
Disease progression 
• 
Decreased white blood cells, red blood cells, and/or platelets which may manifest with fever, 
feeling cold, infections, shortness of breath, feeling tired, a tendency to bruise easily, or a 
tendency to bleed easily  
• 
Fatigue 
• 
Fever 
• 
Gastrointestinal stromal tumor 
• 
Hand and Foot syndrome (redness, pain, swelling or peeling of the palms of the hands or 
soles of the feet) 
• 
Heart attack or heart failure which may cause shortness of breath, swelling of ankles and 
tiredness 
• 
Kidney failure which may require dialysis 
• 
Liver failure 
• 
Loss of body fluid manifesting as feeling tired, confused, having a dry mouth, or feeling 
thirsty (dehydration) 
• 
Low white blood cell count (neutropenia) that could increase the risk of infection 
• 
Multi-organ failure 
• 
Nausea 
• 
Flesh eating bacteria syndrome 
• 
Pneumonia 
• 
Respiratory failure 
• 
Brain damage which may cause headache, seizure, blindness, high blood pressure, decreased 
alertness, blindness (also known as reversible posterior leukoencephalopathy syndrome 
(RPLS)) 
• 
Sepsis 


MEDICAL RECORD 
CONTINUATION SHEET for either: 
NIH 2514-1, Consent to Participate in A Clinical Research Study 
NIH 2514-2, Minor Patient’s Assent to Participate In A Clinical Research 
Study 
STUDY NUMBER:     18-C-0137 
CONTINUATION: page 10 of 16 pages 
 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
NIH-2514-1 (07-09) 
NIH-2514-2 (10-84) 
P.A.:  09-25-0099 
File in Section 4:  Protocol Consent 
 
• 
Severe skin rash with blisters and peeling which can involve the mouth and other parts of the 
body 
• 
Shortness of breath 
• 
Tumor lysis syndrome (Tumor cells spread to blood stream and cause complications) 
• 
Vomiting 
Potential Benefits of Participation 
Are there benefits to taking part in this study? 
The aim of this study is to see if Sunitinib will cause your tumor to shrink. We do not know if 
you will receive personal, medical benefit from taking part in this study.  These potential benefits 
could include shrinking of your tumor or lessening of your symptoms, such as pain, that are 
caused by the cancer.  Because there is not much information about the drug’s effect on your 
cancer, we do not know if you will benefit from taking part in this study, although the knowledge 
gained from this study may help others in the future who have cancer.   
Alternative Approaches or Treatments 
What other choices do I have if I do not take part in this study? 
Instead of being in this study, you have these options: 
• Getting treatment or care for your cancer without being in a study 
• Taking part in another study 
• Getting comfort care, also called palliative care.  This type of care helps reduce pain, 
tiredness, appetite problems and other problems caused by the cancer.  It does not treat 
the cancer directly.  Instead, it tries to improve how you feel.  Comfort care tries to keep 
you as active and comfortable as possible. 
Please talk to your doctor about these and other options. 
Stopping Therapy 
Your doctor may decide to stop your therapy for the following reasons: 
• if he/she believes that it is in your best interest 
• if your disease comes back during treatment 


MEDICAL RECORD 
CONTINUATION SHEET for either: 
NIH 2514-1, Consent to Participate in A Clinical Research Study 
NIH 2514-2, Minor Patient’s Assent to Participate In A Clinical Research 
Study 
STUDY NUMBER:     18-C-0137 
CONTINUATION: page 11 of 16 pages 
 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
NIH-2514-1 (07-09) 
NIH-2514-2 (10-84) 
P.A.:  09-25-0099 
File in Section 4:  Protocol Consent 
 
• if you have side effects from the treatment that your doctor thinks are too severe 
• if new information shows that another treatment would be better for you 
• if you become pregnant 
In this case, you will be informed of the reason therapy is being stopped. 
You can stop taking part in the study at any time. However, if you decide to stop taking part in 
the study, we would like you to talk to the study doctor and your regular doctor first. 
If you decide at any time to withdraw your consent to participate in the trial, we will not collect 
any additional medical information about you. However, according to FDA guidelines, 
information collected on you up to that point may still be provided to Pfizer and Clinical Director 
or Deputy Clinical Director, CCR, NCI or designated representatives. If you withdraw your 
consent and leave the trial, any samples of yours that have been obtained for the study and stored 
at the NCI can be destroyed upon request. However, any samples and data generated from the 
samples that have already been distributed to other researchers or placed in the research 
databases cannot be recalled and destroyed. 
Research Subject’s Rights 
What are the costs of taking part in this study? 
If you choose to take part in the study, the following will apply, in keeping with the NIH policy: 
You will receive study treatment at no charge to you. This may include surgery, medicines, 
laboratory testing, x-rays or scans done at the Clinical Center, National Institutes of Health 
(NIH), or arranged for you by the research team to be done outside the Clinical Center, NIH if 
the study related treatment is not available at the NIH. 
There are limited funds available to cover the cost of some tests and procedures performed 
outside the Clinical Center, NIH.  You may have to pay for these costs if they are not covered by 
your insurance company. 
Medicines that are not part of the study treatment will not be provided or paid for by the Clinical 
Center, NIH. 
Once you have completed taking part in the study, medical care will no longer be provided by 
the Clinical Center, NIH. 


MEDICAL RECORD 
CONTINUATION SHEET for either: 
NIH 2514-1, Consent to Participate in A Clinical Research Study 
NIH 2514-2, Minor Patient’s Assent to Participate In A Clinical Research 
Study 
STUDY NUMBER:     18-C-0137 
CONTINUATION: page 12 of 16 pages 
 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
NIH-2514-1 (07-09) 
NIH-2514-2 (10-84) 
P.A.:  09-25-0099 
File in Section 4:  Protocol Consent 
 
Will your medical information be kept private? 
We will do our best to make sure that the personal information in your medical record will be 
kept private.  However, we cannot guarantee total privacy.  Organizations that may look at 
and/or copy your medical records for research, quality assurance, and data analysis include: 
• The National Cancer Institute (NCI) and other government agencies, like the Food and 
Drug Administration (FDA), which are involved in keeping research safe for people. 
• National Cancer Institute Institutional Review Board 
• Qualified representatives from Pfizer, Inc., the pharmaceutical company who produces 
Sunitinib. 
A description of this clinical trial will be available on http://www.Clinicaltrials.gov, as required 
by U.S. Law.  This Web site will not include information that can identify you.  At most the Web 
site will include a summary of the results. You can search this Web site at any time. 
Certificate of Confidentiality  
To help us protect your privacy, we have obtained a Certificate of Confidentiality. The 
researchers can use this Certificate to legally refuse to disclose information that may identify you 
in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, for 
example, if there is a court subpoena. The researchers will use the Certificate to resist any 
demands for information that would identify you, except as explained below. 
You should also know that there are several circumstances in which the Certificate does not 
provide coverage. These include when information:  
• will be used for auditing or program evaluation internally by the NIH; or  
• must be disclosed to meet the legal requirements of the federal Food and Drug 
Administration (FDA).  
• is necessary for your medical treatment and you have consented to this disclosure;  
• is for other research.  
In addition, identifiable, sensitive information protected by this Certificate cannot be admissible 
as evidence or used for any purpose in any action, suit, or proceeding without your consent.  
You should understand that a Certificate of Confidentiality does not prevent you or a member of 
your family from voluntarily releasing information about yourself or your involvement in this 


MEDICAL RECORD 
CONTINUATION SHEET for either: 
NIH 2514-1, Consent to Participate in A Clinical Research Study 
NIH 2514-2, Minor Patient’s Assent to Participate In A Clinical Research 
Study 
STUDY NUMBER:     18-C-0137 
CONTINUATION: page 13 of 16 pages 
 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
NIH-2514-1 (07-09) 
NIH-2514-2 (10-84) 
P.A.:  09-25-0099 
File in Section 4:  Protocol Consent 
 
research. If an insurer, employer, or other person obtains your written consent to receive research 
information, then the researchers will not use the Certificate to withhold that information. 
The Certificate of Confidentiality will not protect against the required reporting by hospital staff 
of information on suspected child abuse, reportable communicable diseases, and/or possible 
threat of harm to self or others. 
Conflict of Interest 
The National Institutes of Health (NIH) reviews NIH staff researchers at least yearly for conflicts 
of interest.  This process is detailed in a Protocol Review Guide.  You may ask your research 
team for a copy of the Protocol Review Guide or for more information.  Members of the research 
team who do not work for NIH are expected to follow these guidelines but they do not need to 
report their personal finances to the NIH. 
Members of the research team working on this study may have up to $15,000 of stock in the 
companies that make products used in this study.  This is allowed under federal rules and is not a 
conflict of interest.  
Pfizer Inc. is providing Sunitinib for this study to NIH without charge. No NIH investigator 
involved in this study receives payments or other benefits from any company whose drug, 
product or device is being tested.  However, there are some non-NIH collaborators on this study 
who may receive payments or benefits, limited by the rules of their workplace. 
 Use of Specimens and Data for Future Research 
To advance science, it is helpful for researchers to share information they get from studying 
human samples.  They do this by putting it into one or more scientific databases, where it is 
stored along with information from other studies. A researcher who wants to study the 
information must apply to the database and be approved.  Researchers use specimens and data 
stored in scientific databases to advance science and learn about health and disease.   
We plan to keep some of your specimens and data that we collect and use them for future 
research and share them with other researchers. We will not contact you to ask about each of 
these future uses.  These specimens and data will be stripped of identifiers such as name, address 
or account number, so that they may be used for future research on any topic and shared broadly 
for research purposes. Your specimens and data will be used for research purposes only and will 
not benefit you.  It is also possible that the stored specimens and data may never be used.  
Results of research done on your specimens and data will not be available to you or your doctor.  
It might help people who have cancer and other diseases in the future.   


MEDICAL RECORD 
CONTINUATION SHEET for either: 
NIH 2514-1, Consent to Participate in A Clinical Research Study 
NIH 2514-2, Minor Patient’s Assent to Participate In A Clinical Research 
Study 
STUDY NUMBER:     18-C-0137 
CONTINUATION: page 14 of 16 pages 
 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
NIH-2514-1 (07-09) 
NIH-2514-2 (10-84) 
P.A.:  09-25-0099 
File in Section 4:  Protocol Consent 
 
If you do not want your stored specimens and data used for future research, please contact us in 
writing and let us know that you do not want us to use your specimens and/or data.  Then any 
specimens that have not already been used or shared will be destroyed and your data will not be 
used for future research. However, it may not be possible to withdraw or delete materials or data 
once they have been shared with other researchers. 
 
 


MEDICAL RECORD 
CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY 
• 
Adult Patient or 
• Parent, for Minor Patient 
STUDY NUMBER:  18-C-0137 
CONTINUATION: page 15 of 16 pages 
 
PATIENT IDENTIFICATION 
CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH 
STUDY (Continuation Sheet) 
• Adult Patient or 
• Parent, for Minor Patient 
NIH-2514-1 (07-09) 
P.A.:  09-25-0099 
 
File in Section 4:  Protocol Consent 
 
 
OTHER PERTINENT INFORMATION 
1. 
Confidentiality.  When results of an NIH research study are reported in medical journals 
or at scientific meetings, the people who take part are not named and identified.  In most cases, 
the NIH will not release any information about your research involvement without your written 
permission.  However, if you sign a release of information form, for example, for an insurance 
company, the NIH will give the insurance company information from your medical record.  This 
information might affect (either favorably or unfavorably) the willingness of the insurance 
company to sell you insurance. 
The Federal Privacy Act protects the confidentiality of your NIH medical records.  However, you 
should know that the Act allows release of some information from your medical record without 
your permission, for example, if it is required by the Food and Drug Administration (FDA), 
members of Congress, law enforcement officials, or authorized hospital accreditation 
organizations. 
2. 
Policy Regarding Research-Related Injuries.  The Clinical Center will provide short-
term medical care for any injury resulting from your participation in research here.  In general, 
no long-term medical care or financial compensation for research-related injuries will be 
provided by the National Institutes of Health, the Clinical Center, or the Federal Government.  
However, you have the right to pursue legal remedy if you believe that your injury justifies such 
action. 
3. 
Payments.  The amount of payment to research volunteers is guided by the National 
Institutes of Health policies.  In general, patients are not paid for taking part in research studies at 
the National Institutes of Health.  Reimbursement of travel and subsistence will be offered 
consistent with NIH guidelines. 
4. 
Problems or Questions.  If you have any problems or questions about this study, or 
about your rights as a research participant, or about any research-related injury, contact the 
Principal Investigator, Mark Gilbert, M.D., Building 82, Room 235A, Telephone: 240-760-6023. 
You may also call the Clinical Center Patient Representative at 301-496-2626. If you have any 
questions about the use of your specimens or data for future research studies, you may also 
contact the Office of the Clinical Director, Telephone:  240-760-6070. 
5. 
Consent Document.  Please keep a copy of this document in case you want to read it 
again. 
 


MEDICAL RECORD 
CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY 
• 
Adult Patient or 
• Parent, for Minor Patient 
STUDY NUMBER:  18-C-0137 
CONTINUATION: page 16 of 16 pages 
 
PATIENT IDENTIFICATION 
CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH 
STUDY (Continuation Sheet) 
• Adult Patient or 
• Parent, for Minor Patient 
NIH-2514-1 (07-09) 
P.A.:  09-25-0099 
 
File in Section 4:  Protocol Consent 
 
 
COMPLETE APPROPRIATE ITEM(S) BELOW: 
A. Adult Patient’s Consent 
B. Parent’s Permission for Minor Patient. 
I have read the explanation about this study 
and have been given the opportunity to discuss 
it and to ask questions.  I hereby consent to 
take part in this study. 
I have read the explanation about this study 
and have been given the opportunity to 
discuss it and to ask questions.  I hereby give 
permission for my child to take part in this 
study.   
(Attach NIH 2514-2, Minor’s Assent, if 
applicable.) 
 
  
  
 
 
 
Signature of Adult Patient/ 
Legal Representative 
Date 
Signature of Parent(s)/ 
Guardian 
Date 
 
 
Print Name 
 
 
Print Name 
C. Child’s Verbal Assent (If Applicable) 
The information in the above consent was described to my child and my child agrees to 
participate in the study. 
 
  
  
 
Signature of Parent(s)/Guardian 
Date 
Print Name 
THIS CONSENT DOCUMENT HAS BEEN APPROVED FOR USE  
FROM JUNE 16, 2020 THROUGH JUNE 15, 2021.  
 
 
 
 
 
  
 
Signature of Investigator 
Date 
Signature of Witness 
Date 
 
 
Print Name 
 
 
Print Name 
 

Prot_SAP_002.pdf: 
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