Clinical trial: NCT03041701
Section: Alternatives
Subsections: What Is The Usual Approach To My Cancer?|What Is The Usual Approach To My Cancer?|What Are My Other Choices If I Do Not Take Part In This Study?|What Are My Other Choices If I Do Not Take Part In This Study?|What Is The Usual Approach To My Diagnosis?|What Is The Usual Approach To My Cancer?|What Is The Usual Approach To My Cancer?|What Are My Other Choices If I Do Not Take Part In This Study?|What Are My Other Choices If I Do Not Take Part In This Study?

You are being asked to participate in this trial because you have ERMS or ARMS and the other known treatments for your disorder, such as surgery, radiation therapy or chemotherapy, have not proven effective for you. People who are not in a study are usually treated with surgical removal of their tumor, radiation, and/or chemotherapy. You may decide not to receive any treatment directed at shrinking your tumor(s) at this point in time.

You are being asked to participate in this trial because you have ERMS or ARMS and the other known treatments for your disorder, such as surgery, radiation therapy or chemotherapy, have not proven effective for you. People who are not in a study are usually treated with surgical removal of their tumor, radiation, and/or chemotherapy. You may decide not to receive any treatment directed at shrinking your tumor(s) at this point in time.

If you decide not to take part in this study, you have other choices. For example:
you may choose to have the usual approach described above you may choose to take part in a different study, if one is available or you may choose not to be treated for cancer but you may want to receive comfort care to relieve symptoms.  
Please talk to your doctor about these and other options.

If you decide not to take part in this study, you have other choices. For example:
you may choose to have the usual approach described above  
you may choose to take part in a different study, if one is available or you may choose not to be treated for cancer but you may want to receive comfort care to relieve symptoms.
Please talk to your doctor about these and other options.

Rhabdomyosarcoma (RMS) is the most common soft tissue sarcoma of childhood. Two major types of RMS are embryonal rhabdomyosarcoma (ERMS) and alveolar rhabdomyosarcoma
(ARMS). The treatments for RMS include surgery, radiation therapy or chemotherapy. Some of the agents used to treat rhabdomyosarcoma are approved by the U.S. Food and Drug Administration (FDA) for other indications. New types of treatments being tested in clinical trials include high-dose chemotherapy with stem cell transplant, immunotherapy, or targeted therapy.  
The insulin-like growth factor (IGF) system plays an important role in many cancers. Overexpression of the type 1 IGF receptor (IGF-1R) has been observed in sarcoma. An enzyme called YES is also highly expressed in both ERMS and ARMS. Treatment blocking both IGF and YES appears to slow tumor growth of ERMS and ARMS cells studied in the laboratory. Dasatinib is an enzyme inhibitor that may block over-expression of YES. Dasatinib also appears to have anticancer activity in some cancers. Ganitumab is a monoclonal antibody directed specifically against IGF-1R to suppress tumor growth.

You are being asked to participate in this trial because you have ERMS or ARMS and the other known treatments for your disorder, such as surgery, radiation therapy or chemotherapy, have not proven effective for you. People who are not in a study are usually treated with surgical removal of their tumor, radiation, and/or chemotherapy. You may decide not to receive any treatment directed at shrinking your tumor(s) at this point in time.

You are being asked to participate in this trial because you have ERMS or ARMS and the other known treatments for your disorder, such as surgery, radiation therapy or chemotherapy, have not proven effective for you. People who are not in a study are usually treated with surgical removal of their tumor, radiation, and/or chemotherapy. You may decide not to receive any treatment directed at shrinking your tumor(s) at this point in time.

If you decide not to take part in this study, you have other choices. For example:
you may choose to have the usual approach described above you may choose to take part in a different study, if one is available or you may choose not to be treated for cancer but you may want to receive comfort care to relieve symptoms.  
Please talk to your doctor about these and other options.

If you decide not to take part in this study, you have other choices. For example:
you may choose to have the usual approach described above  
you may choose to take part in a different study, if one is available or you may choose not to be treated for cancer but you may want to receive comfort care to relieve symptoms.
Please talk to your doctor about these and other options.
Clinical trial: NCT03041701
Section: Confidentiality
Subsections: Confidentiality Protections Provided In This Study Will Your Medical Information Be Kept Private?|Certificate Of Confidentiality|Privacy Act|Who Will See My Medical Information?|How Will Information About Me 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 NIH and other government agencies, like the Food and Drug Administration (FDA),
which are involved in keeping research safe for people.  
National Institutes of Health Intramural Institutional Review Board The study sponsor and any drug company supporting the study.  
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. If we share your specimens or data with other researchers, in most circumstances we will remove your identifiers before sharing your specimens or data. You should be aware that there is a slight possibility that someone could figure out the information is about you. Further, the information collected for this study is protected by NIH under a Certificate of Confidentiality and the Privacy Act. Your study records also will be stored for future use. However, your name and other personal information will not be used. Some types of future research may include looking at your records and those of other patients to see who had side effects across many studies or comparing new study data with older study data. However, we don't know what research may be done in the future using your information. This means that:  
You will not be asked if you agree to take part in the specific future research studies using your health information.  
You and your study doctor will not be told when or what type of research will be done.
You will not get reports or other information about any research that is done using your information.

To help us protect your privacy, the NIH Intramural Program has received a Certificate of Confidentiality (Certificate). With this certificate, researchers may not release or use data or information about you except in certain circumstances. NIH researchers must not share information that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, for example, if requested by a court. The Certificate does not protect your information when it:  
1. is disclosed to people connected with the research, for example, information may be used for auditing or program evaluation internally by the NIH; or 2. is required to be disclosed by Federal, State, or local laws, for example, when information must be disclosed to meet the legal requirements of the federal Food and Drug Administration (FDA);
3. is for other research; 4. is disclosed with your consent.
The Certificate does not prevent you from voluntarily releasing information about yourself or your involvement in this research. The Certificate will not be used to prevent disclosure to state or local authorities of harm to self or others including, for example, child abuse and neglect, and by signing below you consent to those disclosures. Other permissions for release may be made by signing NIH forms, such as the Notice and Acknowledgement of Information Practices consent.  
PATIENT IDENTIFICATION **Consent to Participate in a Clinical Research Study**  
NIH-2977 (4-17) File in Section 4: Protocol Consent (1) Version Date: 03/03/2020 Page 14 of 17  
CC ICF template v. 09.27.19

The Federal Privacy Act generally protects the confidentiality of your NIH medical records we collect under the authority of the Public Health Service Act. In some cases, the Privacy Act protections differ from the Certificate of Confidentiality. For example, sometimes the Privacy Act allows release of information from your medical record without your permission, for example, if it is requested by Congress. Information may also be released for certain research purposes with due consideration and protection, to those engaged by the agency for research purposes, to certain federal and state agencies, for HIV partner notification, for infectious disease or abuse or neglect reporting, to tumor registries, for quality assessment and medical audits, or when the NIH is involved in a lawsuit. However, NIH will only release information from your medical record if it is permitted by both the Certificate of Confidentiality and the Privacy Act.

The NCI has recommended that HIPAA regulations be addressed by the local institution. Language pertaining to HIPAA compliance may or may not be included in the local consent form, depending on local institutional policy. Your privacy is very important to us and the researchers will make every effort to protect it. Your information may be given out if required by law. For example, certain states require doctors to report to health boards if they find a disease like tuberculosis. However, the researchers will do their best to make sure that any information that is released will not identify you. Some of your health information, and/or information about your specimen, from this study will be kept in a central database for research. Your name or contact information will not be put in the database.  
There are organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis. These organizations are required to make sure your information is kept private, unless required by law to provide information. Some of these organizations are:
Qualified representatives from the pharmaceutical collaborator, maker of selumetinib.  
The Institutional Review Board, IRB, is a group of people who review the research with the goal of protecting the people who take part in the study.  
Representatives of the National Cancer Institute (NCI) and other government agencies, like the Food and Drug Administration (FDA), involved in overseeing research

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. The remaining specimens and your data will be identified by a number only. Only the study investigator and research team taking care of you on this study will have access to your name.
Clinical trial: NCT03041701
Section: Duration of Study Involvement
Subsections: How Long Will I Be In This Study?|How Long Will I Be In This Study?|How Long Will I Be In This Study?|How Long Will I Be In This Study?

You will take the dasatinib every day for 35 days during the first cycle, and for 28 days in subsequent cycles. You will be given the ganitumab once every 2 weeks. You can continue to take dasatinib-ganitumab as long as you do not have unacceptable toxicities or your tumor(s) do not get worse. If you have side effects the dose of dasatinib and/or ganitumab may be held for a short time and the dose(s) may be reduced to prevent return of the side effect. Two dose reductions for dasatinib and one dose reduction for ganitumab are allowed on this study. If the side effect(s) is too severe, or side effect(s) recur after the dose reductions, dasatinib-ganitumab may need to be stopped.

You will take the dasatinib every day for 35 days during the first cycle, and for 28 days in subsequent cycles. You will be given the ganitumab once every 2 weeks. You can continue to take dasatinib-ganitumab as long as you do not have unacceptable toxicities or your tumor(s) do not get worse. If you have side effects the dose of dasatinib and/or ganitumab may be held for a short time and the dose(s) may be reduced to prevent return of the side effect. Two dose reductions for dasatinib and one dose reduction for ganitumab are allowed on this study. If the side effect(s) is too severe, or side effect(s) recur after the dose reductions, dasatinib-ganitumab may need to be stopped.

You will take the dasatinib every day for 35 days during the first cycle, and for 28 days in subsequent cycles. You will be given the ganitumab once every 2 weeks. You can continue to take dasatinib-ganitumab as long as you do not have unacceptable toxicities or your tumor(s) do not get worse. If you have side effects the dose of dasatinib and/or ganitumab may be held for a short time and the dose(s) may be reduced to prevent return of the side effect. Two dose reductions for dasatinib and one dose reduction for ganitumab are allowed on this study. If the side effect(s) is too severe, or side effect(s) recur after the dose reductions, dasatinib-ganitumab may need to be stopped.

You will take the dasatinib every day for 35 days during the first cycle, and for 28 days in subsequent cycles. You will be given the ganitumab once every 2 weeks. You can continue to take dasatinib-ganitumab as long as you do not have unacceptable toxicities or your tumor(s) do not get worse. If you have side effects the dose of dasatinib and/or ganitumab may be held for a short time and the dose(s) may be reduced to prevent return of the side effect. Two dose reductions for dasatinib and one dose reduction for ganitumab are allowed on this study. If the side effect(s) is too severe, or side effect(s) recur after the dose reductions, dasatinib-ganitumab may need to be stopped.
Clinical trial: NCT03041701
Section: Participant's Rights
Subsections: What Are My Rights In This Study?

Taking part in this study is your choice. No matter what decision you make, and even if your decision changes, there will be no penalty to you. You will not lose medical care or any legal rights. For questions about your rights while in this study, call the ________________________ (insert name of center) Institutional Review Board at __________________ *(insert telephone number).* (Note to Local Investigator: Contact information for patient representatives or other individuals at a local institution who are not on the IRB or research team but take calls regarding clinical trial questions can also be listed here.)
Clinical trial: NCT03041701
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: A Study Calendar That Shows How Often These Tests And Procedures Will Be Done Is Attached. What Possible Risks Can I Expect From Taking Part In This Study?|Risks Of Dasatinib Common, Some May Be Serious|Occasional, Some May Be Serious|Occasional, Some May Be Serious|Rare, And Serious|Rare, And Serious|Rare, And Serious|Rare, And Serious|Risks Of Ganitumab Common, Some May Be Serious|Risks Of Ganitumab Common, Some May Be Serious|Rare, And Serious|Rare, And Serious|Rare, And Serious|Rare, And Serious|What Possible Benefits Can I Expect From Taking Part In This Study?|What Possible Benefits Can I Expect From Taking Part In This Study?|Are There Any Costs Or Payments?|Are There Any Costs Or Payments?|Are There Any Costs Or Payments?|Study Calendar Compensation, Reimbursement, And Payment Will You Receive Compensation For Participation In The Study?|Will Taking Part In This Research Study Cost You Anything?|Policy Regarding Research-Related Injuries|During The Study: A Study Calendar That Shows How Often These Tests And Procedures Will Be Done Is Attached. What Possible Risks Can I Expect From Taking Part In This Study?|Risks Of Dasatinib|Occasional, Some May Be Serious In 100 People Receiving Dasatinib, From 4 To 20 May Have:|Rare, And Serious|Rare, And Serious|Rare, And Serious|Rare, And Serious|Risks Of Ganitumab Common, Some May Be Serious|Risks Of Ganitumab Common, Some May Be Serious|Occasional, Some May Be Serious|Occasional, Some May Be Serious|Rare, And Serious|Rare, And Serious|Rare, And Serious|Rare, And Serious|What Possible Benefits Can I Expect From Taking Part In This Study?|What Possible Benefits Can I Expect From Taking Part In This Study?|What Are The Costs Of Taking Part In This Study?|What Happens If I Am Injured Or Hurt Because I Took Part In This Study?|Are There Any Costs Or Payments?|Are There Any Costs Or Payments?|Are There Any Costs Or Payments?|What Are The Possible Benefits?|Are There Any Costs Or Payments?|Are There Any Costs Or Payments?|Are There Any Costs Or Payments?

If you choose to take part in this study, there is a risk that ganitumab (AMG 479) and dasatinib may not be as good as the usual approach for your cancer or condition at shrinking or stabilizing your cancer. You also may have the following discomforts:  
Spend more time in the hospital or doctor's office.  
Be asked sensitive or private questions which you normally do not discuss May not be able to take part in future studies
The ganitumab (AMG 479) and dasatinib used in this study may affect how different parts of your body work such as your liver, kidneys, heart, and blood. The study doctor will test your blood and will let you know if changes occur that may affect your health. There is also a risk that you could have side effects from the study drugs. Here are important points about side effects:  
The study doctors do not know who will or will not have side effects.  
Some side effects may go away soon, some may last a long time, or some may never go away.  
Some side effects may interfere with your ability to have children.  
Some side effects may be mild. Other side effects may be very serious and even result in death.
You can ask your study doctor questions about side effects at any time. Here are important points about how you and the study doctor can make side effects less of a problem:
If you notice or feel anything different, tell your study doctor. He or she can check to see if it is a side effect.  
Your study doctor will work with you to treat your side effects.  
Your study doctor may adjust the study drugs to try to reduce side effects.  
The tables below show the most common and the most serious side effects doctors know about. There might be other side effects doctors do not yet know about. If important new side effects are found, the study doctor will discuss these with you.

In 100 people receiving dasatinib, more than 20 and up to 100 may have:
Anemia which may require blood transfusion Diarrhea, nausea Tiredness Bruising, bleeding Pain Headache Shortness of breath Fluid in the body Rash OCCASIONAL, SOME MAY BE SERIOUS
In 100 people receiving dasatinib, from 4 to 20 may have:
Infection, especially when white blood cell count is low Bloating, constipation, heartburn, vomiting Bleeding from multiple sites Internal bleeding which may cause black tarry stool or blood in vomit Sores in the mouth which may cause difficulty swallowing Swelling of the body Fever Weight gain Weight loss, loss of appetite Dizziness PATIENT IDENTIFICATION **Consent to Participate in a Clinical Research Study**
NIH-2977 (4-17) File in Section 4: Protocol Consent (1) Version Date: 03/03/2020 Page 6 of 17 CC ICF template v. 09.27.19

In 100 people receiving dasatinib, from 4 to 20 may have:
Cough, sore throat Damage to organs (lungs, brain, others) which may cause shortness of breath, changes in thinking Hair loss, itching, acne Flushing

In 100 People Receiving Ganitumab (Amg 479), From 4 To 20 May Have:  
Anemia which may require blood transfusion
Diarrhea, nausea, vomiting Bruising, bleeding  
  
  
Loss of appetite Pain in muscles Rash

In 100 people receiving dasatinib, 3 or fewer may have:
Heart failure, heart attack which may cause shortness of breath, swelling of ankles, and tiredness Change in the heart rhythm Kidney damage which may require dialysis Bone growth may stop early in teenagers leading to short stature Loss of bone tissue Decreased height in children and adolescents Enlarged breasts in males Bleeding in the brain which may cause confusion Brain damage which may cause headache, seizure, blindness (also known as Reversible Posterior Leukoencephalopathy Syndrome)
Severe skin rash with blisters and peeling which can involve mouth and other parts of the body Inflammation of the lungs which can cause shortness of breath and difficulty breathing

In 100 people receiving Ganitumab (AMG 479), 3 or fewer may have:  
  
Hearing loss Ganitumab may cause damage to the lung that may cause shortness of breath when receiving radiotherapy to the lungs shortly before or after treatment with ganitumab.  
Reproductive Risks: You should not become pregnant or father a baby while on this study because the drugs in this study can affect an unborn baby. Women should not breastfeed a baby while on this study. It is important you understand that you need to use birth control while on this study. Both male and female participants must use effective birth control measures while participating in this study and for at least 4 months after the last dose of dasatinib-ganitumab. Check with your study doctor about what kind of birth control methods to use and how long to use them. Some methods might not be approved for use in this study. Optional birth control methods include, but are not limited to, abstinence, oral birth control pills, an IUD, or condoms with spermicide. If you are a woman and become pregnant or suspect you are pregnant while participating in this study, please inform your treating physician immediately. A patient who becomes pregnant while on study will immediately be taken off study.

In 100 people receiving dasatinib, 3 or fewer may have:
Bone growth may stop early in teenagers leading to short stature Loss of bone tissue Decreased height in children and adolescents Enlarged breasts in males Bleeding in the brain which may cause confusion Brain damage which may cause headache, seizure, blindness (also known as Reversible Posterior Leukoencephalopathy Syndrome)
Severe skin rash with blisters and peeling which can involve mouth and other parts of the body Inflammation of the lungs which can cause shortness of breath and difficulty breathing Heart failure, heart attack which may cause shortness of breath, swelling of ankles, and tiredness Change in the heart rhythm Kidney damage which may require dialysis

In 100 people receiving Ganitumab (AMG 479), 3 or fewer may have:  
Hearing loss  
  
Reproductive Risks: You should not become pregnant or father a baby while on this study because the drugs in this study can affect an unborn baby. Women should not breastfeed a baby while on this study. It is important you understand that you need to use birth control while on this study. Both male and female participants must use effective birth control measures while participating in this study and for at least 4 months after the last dose of dasatinib-ganitumab. Check with your study doctor about what kind of birth control methods to use and how long to use them. Some methods might not be approved for use in this study. Optional birth control methods include, but are not limited to, abstinence, oral birth control pills, an IUD, or condoms with spermicide. If you are a woman and become pregnant or suspect you are pregnant while participating in this study, please inform your treating physician immediately. A patient who becomes pregnant while on study will immediately be taken off study.

In 100 people receiving Ganitumab (AMG 479), more than 20 and up to 100 may have:
Tiredness Reaction during or following a drug infusion which may cause fever, chills, low blood pressure

In 100 people receiving Ganitumab (AMG 479), more than 20 and up to 100 may have:  
Tiredness Reaction during or following a drug infusion which may cause fever, chills, low blood pressure

In 100 people receiving dasatinib, 3 or fewer may have:
Heart failure, heart attack which may cause shortness of breath, swelling of ankles, and tiredness Change in the heart rhythm Kidney damage which may require dialysis Bone growth may stop early in teenagers leading to short stature Loss of bone tissue Decreased height in children and adolescents Enlarged breasts in males Bleeding in the brain which may cause confusion Brain damage which may cause headache, seizure, blindness (also known as Reversible Posterior Leukoencephalopathy Syndrome)
Severe skin rash with blisters and peeling which can involve mouth and other parts of the body Inflammation of the lungs which can cause shortness of breath and difficulty breathing

In 100 people receiving Ganitumab (AMG 479), 3 or fewer may have:  
  
Hearing loss Ganitumab may cause damage to the lung that may cause shortness of breath when receiving radiotherapy to the lungs shortly before or after treatment with ganitumab.  
Reproductive Risks: You should not become pregnant or father a baby while on this study because the drugs in this study can affect an unborn baby. Women should not breastfeed a baby while on this study. It is important you understand that you need to use birth control while on this study. Both male and female participants must use effective birth control measures while participating in this study and for at least 4 months after the last dose of dasatinib-ganitumab. Check with your study doctor about what kind of birth control methods to use and how long to use them. Some methods might not be approved for use in this study. Optional birth control methods include, but are not limited to, abstinence, oral birth control pills, an IUD, or condoms with spermicide. If you are a woman and become pregnant or suspect you are pregnant while participating in this study, please inform your treating physician immediately. A patient who becomes pregnant while on study will immediately be taken off study.

In 100 people receiving dasatinib, 3 or fewer may have:
Bone growth may stop early in teenagers leading to short stature Loss of bone tissue Decreased height in children and adolescents Enlarged breasts in males Bleeding in the brain which may cause confusion Brain damage which may cause headache, seizure, blindness (also known as Reversible Posterior Leukoencephalopathy Syndrome)
Severe skin rash with blisters and peeling which can involve mouth and other parts of the body Inflammation of the lungs which can cause shortness of breath and difficulty breathing Heart failure, heart attack which may cause shortness of breath, swelling of ankles, and tiredness Change in the heart rhythm Kidney damage which may require dialysis

In 100 people receiving Ganitumab (AMG 479), 3 or fewer may have:  
Hearing loss  
  
Reproductive Risks: You should not become pregnant or father a baby while on this study because the drugs in this study can affect an unborn baby. Women should not breastfeed a baby while on this study. It is important you understand that you need to use birth control while on this study. Both male and female participants must use effective birth control measures while participating in this study and for at least 4 months after the last dose of dasatinib-ganitumab. Check with your study doctor about what kind of birth control methods to use and how long to use them. Some methods might not be approved for use in this study. Optional birth control methods include, but are not limited to, abstinence, oral birth control pills, an IUD, or condoms with spermicide. If you are a woman and become pregnant or suspect you are pregnant while participating in this study, please inform your treating physician immediately. A patient who becomes pregnant while on study will immediately be taken off study.

Treatment with dasatinib-ganitumab may cause your tumor(s) to stop growing or shrink or it may lessen the symptoms, such as pain, that are caused by the tumor. However, because there is not much information about the combination of the drugs' effects on your type of tumor, we do not know if you will benefit from taking part in this study, although the knowledge gained from this study may benefit others. Your samples may be helpful to research. The researchers, using the samples from you and others, might make discoveries that could help people in the future.

Treatment with dasatinib-ganitumab may cause your tumor(s) to stop growing or shrink or it may lessen the symptoms, such as pain, that are caused by the tumor. However, because there is not much information about the combination of the drugs' effects on your type of tumor, we do not know if you will benefit from taking part in this study, although the knowledge gained from this study may benefit others. Your samples may be helpful to research. The researchers, using the samples from you and others, might make discoveries that could help people in the future.

There are no costs to you. You will not be paid for your tissue. The cost of biopsy, storage and testing will be paid by the study investigators or collaborators in this study. What if I change my mind? If you decide now that you will undergo the biopsy, you can change your mind at any time. Just let us know at the time of the biopsy or contact us (office of Dr. Heske, Principal Investigator: 240-760-6197) and let us know that you do not want to have the biopsy. What if I have more questions? If you have additional questions, please contact the office of Dr. Heske, Principal Investigator: 240-760-6197. Please circle your answer: I choose to take part in the tumor biopsy:
YES NO

There are no costs to you. You will not be paid for your tissue. The cost of biopsy, storage and testing will be paid by the study investigators or collaborators in this study. What if I change my mind? If you decide now that you will undergo the biopsy, you can change your mind at any time. Just let us know at the time of the biopsy or contact us ________________________ (insert name of center) Institutional Review Board at __________________ *(insert telephone number)* and let us know that you do not want to have the biopsy. What if I have more questions? If you have additional questions, please contact the office of Dr. Heske, Principal Investigator: 240-760-6197.  
$$\mathrm{{\sl~als.}_{-}}$$
$\square$
Yes No NA Initials:_______ Date: ________ This is the end of the section about optional studies.

There are no costs to you. You will not be paid for your tissue or data. The cost of storage and testing will be paid by the study investigators or collaborators in this study.

Some NIH Clinical Center studies offer compensation for participation in research. The amount of compensation, if any, is guided by NIH policies and guidelines. You will not receive compensation for participation in this study. Will you receive reimbursement or direct payment by NIH as part of your participation? Some NIH Clinical Center studies offer reimbursement or payment for travel, lodging or meals while participating in the research. The amount, if any, is guided by NIH policies and guidelines. The NCI generally does not cover expenses during screening. If you are scheduled for and begin treatment, the NCI will cover the cost for some of your expenses. Some of these costs may be paid directly by the NIH and some may be reimbursed after you have paid. Someone will work with you to provide more information.

NIH does not bill health insurance companies or participants for any research or related clinical care that you receive at the NIH Clinical Center.  
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.

The NIH 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 NIH, the NIH Clinical Center, or the Federal Government. However, you have the right to pursue legal remedy if you believe that your injury justifies such action. Your insurance company may not be willing to pay for study-related injury. If you have no insurance, you may be responsible for any costs.

EKG will be done before each cycle.  
At the end of treatment with dasatinib-ganitumab you will have an evaluation at
______________. At this visit you will have a physical exam, blood and urine tests and scans/xrays to measure your tumor.  
If you choose to take part in this study, there is a risk that ganitumab (AMG 479) and dasatinib may not be as good as the usual approach for your cancer or condition at shrinking or stabilizing your cancer. You also may have the following discomforts:
Spend more time in the hospital or doctor's office.  
The ganitumab (AMG479) and dasatinib used in this study may affect how different parts of your body work such as your liver, kidneys, heart, and blood. The study doctor will test your blood and will let you know if changes occur that may affect your health. There is also a risk that you could have side effects from the study drugs. Here are important points about side effects:
The study doctors do not know who will or will not have side effects.  
Some side effects may go away soon, some may last a long time, or some may never go away.  
Some side effects may interfere with your ability to have children.  
Some side effects may be mild. Other side effects may be very serious and even result in death.
You can ask your study doctor questions about side effects at any time. Here are important points about how you and the study doctor can make side effects less of a problem:  
If you notice or feel anything different, tell your study doctor. He or she can check to see if it is a side effect.  
Your study doctor will work with you to treat your side effects.  
Your study doctor may adjust the study drugs to try to reduce side effects.  
Diarrhea, nausea Bruising, bleeding

|    | Anemia which may require blood transfusion   |
|-----|----------------------------------------------|  
|    | Pain                |
|-----|---------------------|
|    | Headache            |
|    | Shortness of breath |  
|    | Fluid in the body   |
|-----|---------------------|  
|    | Rash   |
|-----|--------|  
Tiredness The tables below show the most common and the most serious side effects doctors know about. There might be other side effects doctors do not yet know about. If important new side effects are found, the study doctor will discuss these with you.

Infection, especially when white blood cell count is low Bloating, constipation, heartburn, vomiting Bleeding from multiple sites Internal bleeding which may cause black tarry stool or blood in vomit Sores in the mouth which may cause difficulty swallowing Swelling of the body Fever Weight gain Weight loss, loss of appetite Dizziness Cough, sore throat Damage to organs (lungs, brain, others) which may cause shortness of breath, changes in thinking Hair loss, itching, acne Flushing

In 100 people receiving dasatinib, 3 or fewer may have:
Heart failure, heart attack which may cause shortness of breath, swelling of ankles, and tiredness Change in the heart rhythm Kidney damage which may require dialysis Bone growth may stop early in teenagers leading to short stature Loss of bone tissue Decreased height in children and adolescents Enlarged breasts in males Bleeding in the brain which may cause confusion Brain damage which may cause headache, seizure, blindness (also known as Reversible Posterior Leukoencephalopathy Syndrome)
Severe skin rash with blisters and peeling which can involve mouth and other parts of the body Inflammation of the lungs which can cause shortness of breath and difficulty breathing

In 100 people receiving Ganitumab (AMG 479), 3 or fewer may have:  
  
Hearing loss Ganitumab may cause damage to the lung that may cause shortness of breath when receiving radiotherapy to the lungs shortly before or after treatment with ganitumab.  
Reproductive Risks: You should not become pregnant or father a baby while on this study because the drugs in this study can affect an unborn baby. Women should not breastfeed a baby while on this study. It is important you understand that you need to use birth control while on this study. Both male and female participants must use effective birth control measures while participating in this study and for at least 4 months after the last dose of dasatinib-ganitumab. Check with your study doctor about what kind of birth control methods to use and how long to use them. Some methods might not be approved for use in this study. Optional birth control methods include, but are not limited to, abstinence, oral birth control pills, an IUD, or condoms with spermicide. If you are a woman and become pregnant or suspect you are pregnant while participating in this study, please inform your treating physician immediately. A patient who becomes pregnant while on study will immediately be taken off study.

In 100 people receiving dasatinib, 3 or fewer may have:
Bone growth may stop early in teenagers leading to short stature Loss of bone tissue Decreased height in children and adolescents Enlarged breasts in males Bleeding in the brain which may cause confusion Brain damage which may cause headache, seizure, blindness (also known as Reversible Posterior Leukoencephalopathy Syndrome)
Severe skin rash with blisters and peeling which can involve mouth and other parts of the body Inflammation of the lungs which can cause shortness of breath and difficulty breathing Heart failure, heart attack which may cause shortness of breath, swelling of ankles, and tiredness Change in the heart rhythm Kidney damage which may require dialysis

In 100 people receiving Ganitumab (AMG 479), 3 or fewer may have:  
Hearing loss  
  
Reproductive Risks: You should not become pregnant or father a baby while on this study because the drugs in this study can affect an unborn baby. Women should not breastfeed a baby while on this study. It is important you understand that you need to use birth control while on this study. Both male and female participants must use effective birth control measures while participating in this study and for at least 4 months after the last dose of dasatinib-ganitumab. Check with your study doctor about what kind of birth control methods to use and how long to use them. Some methods might not be approved for use in this study. Optional birth control methods include, but are not limited to, abstinence, oral birth control pills, an IUD, or condoms with spermicide. If you are a woman and become pregnant or suspect you are pregnant while participating in this study, please inform your treating physician immediately. A patient who becomes pregnant while on study will immediately be taken off study.

In 100 people receiving Ganitumab (AMG 479), more than 20 and up to 100 may have:
Tiredness Reaction during or following a drug infusion which may cause fever, chills, low blood pressure

In 100 people receiving Ganitumab (AMG 479), more than 20 and up to 100 may have:  
Tiredness Reaction during or following a drug infusion which may cause fever, chills, low blood pressure

In 100 people receiving dasatinib, from 4 to 20 may have:
Cough, sore throat Damage to organs (lungs, brain, others) which may cause shortness of breath, changes in thinking Hair loss, itching, acne Flushing

In 100 People Receiving Ganitumab (Amg 479), From 4 To 20 May Have:  
Anemia which may require blood transfusion
Diarrhea, nausea, vomiting Bruising, bleeding  
  
  
Loss of appetite Pain in muscles Rash

In 100 people receiving dasatinib, 3 or fewer may have:
Heart failure, heart attack which may cause shortness of breath, swelling of ankles, and tiredness Change in the heart rhythm Kidney damage which may require dialysis Bone growth may stop early in teenagers leading to short stature Loss of bone tissue Decreased height in children and adolescents Enlarged breasts in males Bleeding in the brain which may cause confusion Brain damage which may cause headache, seizure, blindness (also known as Reversible Posterior Leukoencephalopathy Syndrome)
Severe skin rash with blisters and peeling which can involve mouth and other parts of the body Inflammation of the lungs which can cause shortness of breath and difficulty breathing

In 100 people receiving Ganitumab (AMG 479), 3 or fewer may have:  
  
Hearing loss Ganitumab may cause damage to the lung that may cause shortness of breath when receiving radiotherapy to the lungs shortly before or after treatment with ganitumab.  
Reproductive Risks: You should not become pregnant or father a baby while on this study because the drugs in this study can affect an unborn baby. Women should not breastfeed a baby while on this study. It is important you understand that you need to use birth control while on this study. Both male and female participants must use effective birth control measures while participating in this study and for at least 4 months after the last dose of dasatinib-ganitumab. Check with your study doctor about what kind of birth control methods to use and how long to use them. Some methods might not be approved for use in this study. Optional birth control methods include, but are not limited to, abstinence, oral birth control pills, an IUD, or condoms with spermicide. If you are a woman and become pregnant or suspect you are pregnant while participating in this study, please inform your treating physician immediately. A patient who becomes pregnant while on study will immediately be taken off study.

In 100 people receiving dasatinib, 3 or fewer may have:
Bone growth may stop early in teenagers leading to short stature Loss of bone tissue Decreased height in children and adolescents Enlarged breasts in males Bleeding in the brain which may cause confusion Brain damage which may cause headache, seizure, blindness (also known as Reversible Posterior Leukoencephalopathy Syndrome)
Severe skin rash with blisters and peeling which can involve mouth and other parts of the body Inflammation of the lungs which can cause shortness of breath and difficulty breathing Heart failure, heart attack which may cause shortness of breath, swelling of ankles, and tiredness Change in the heart rhythm Kidney damage which may require dialysis

In 100 people receiving Ganitumab (AMG 479), 3 or fewer may have:  
Hearing loss  
  
Reproductive Risks: You should not become pregnant or father a baby while on this study because the drugs in this study can affect an unborn baby. Women should not breastfeed a baby while on this study. It is important you understand that you need to use birth control while on this study. Both male and female participants must use effective birth control measures while participating in this study and for at least 4 months after the last dose of dasatinib-ganitumab. Check with your study doctor about what kind of birth control methods to use and how long to use them. Some methods might not be approved for use in this study. Optional birth control methods include, but are not limited to, abstinence, oral birth control pills, an IUD, or condoms with spermicide. If you are a woman and become pregnant or suspect you are pregnant while participating in this study, please inform your treating physician immediately. A patient who becomes pregnant while on study will immediately be taken off study.

Treatment with dasatinib-ganitumab may cause your tumor(s) to stop growing or shrink or it may lessen the symptoms, such as pain, that are caused by the tumor. However, because there is not much information about the combination of the drugs' effects on your type of tumor, we do not know if you will benefit from taking part in this study, although the knowledge gained from this study may benefit others. Your samples may be helpful to research. The researchers, using the samples from you and others, might make discoveries that could help people in the future.

Treatment with dasatinib-ganitumab may cause your tumor(s) to stop growing or shrink or it may lessen the symptoms, such as pain, that are caused by the tumor. However, because there is not much information about the combination of the drugs' effects on your type of tumor, we do not know if you will benefit from taking part in this study, although the knowledge gained from this study may benefit others. Your samples may be helpful to research. The researchers, using the samples from you and others, might make discoveries that could help people in the future.

Study treatment will be supplied at no charge while you take part in this study. You and/or your health plan/insurance company will need to pay for all of the other costs of treating your tumors while in this study, including the cost of tests, procedures, or medicines to manage any side effects, unless you are told that certain tests are supplied at no charge. Before you decide to be in the study, you should check with your health plan or insurance company to find out exactly what they will pay for. (Note to consent form authors and investigators: Insert a description of any compensation for participation or reimbursement for expenses.)

If you are injured or hurt as a result of taking part in this study and need medical treatment, please tell your study doctor. The study sponsors will not offer to pay for medical treatment for injury. Your insurance company may not be willing to pay for study-related injury. If you have no insurance, you would be responsible for any costs. If you feel this injury was a result of medical error, you keep all your legal rights to receive payment for this even though you are in a study.

There are no costs to you. You will not be paid for your tissue. The cost of biopsy, storage and testing will be paid by the study investigators or collaborators in this study. What if I change my mind? If you decide now that you will undergo the biopsy, you can change your mind at any time. Just let us know at the time of the biopsy or contact us (office of Dr. Heske, Principal Investigator: 240-760-6197) and let us know that you do not want to have the biopsy. What if I have more questions? If you have additional questions, please contact the office of Dr. Heske, Principal Investigator: 240-760-6197. Please circle your answer: I choose to take part in the tumor biopsy:
YES NO

There are no costs to you. You will not be paid for your tissue. The cost of biopsy, storage and testing will be paid by the study investigators or collaborators in this study. What if I change my mind? If you decide now that you will undergo the biopsy, you can change your mind at any time. Just let us know at the time of the biopsy or contact us ________________________ (insert name of center) Institutional Review Board at __________________ *(insert telephone number)* and let us know that you do not want to have the biopsy. What if I have more questions? If you have additional questions, please contact the office of Dr. Heske, Principal Investigator: 240-760-6197.  
$$\mathrm{{\sl~als.}_{-}}$$
$\square$
Yes No NA Initials:_______ Date: ________ This is the end of the section about optional studies.

There are no costs to you. You will not be paid for your tissue or data. The cost of storage and testing will be paid by the study investigators or collaborators in this study.

The use of your specimens and data will be 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 these types of tumors and other diseases in the future.

There are no costs to you. You will not be paid for your tissue. The cost of biopsy, storage and testing will be paid by the study investigators or collaborators in this study. What if I change my mind? If you decide now that you will undergo the biopsy, you can change your mind at any time. Just let us know at the time of the biopsy or contact us (office of Dr. Heske, Principal Investigator: 240-760-6197) and let us know that you do not want to have the biopsy. What if I have more questions? If you have additional questions, please contact the office of Dr. Heske, Principal Investigator: 240-760-6197. Please circle your answer: I choose to take part in the tumor biopsy:
YES NO

There are no costs to you. You will not be paid for your tissue. The cost of biopsy, storage and testing will be paid by the study investigators or collaborators in this study. What if I change my mind? If you decide now that you will undergo the biopsy, you can change your mind at any time. Just let us know at the time of the biopsy or contact us ________________________ (insert name of center) Institutional Review Board at __________________ *(insert telephone number)* and let us know that you do not want to have the biopsy. What if I have more questions? If you have additional questions, please contact the office of Dr. Heske, Principal Investigator: 240-760-6197.  
$$\mathrm{{\sl~als.}_{-}}$$
$\square$
Yes No NA Initials:_______ Date: ________ This is the end of the section about optional studies.

There are no costs to you. You will not be paid for your tissue or data. The cost of storage and testing will be paid by the study investigators or collaborators in this study.
Clinical trial: NCT03041701
Section: Procedures
Subsections: What Extra Tests And Procedures Will I Have If I Take Part In This Study?|What Extra Tests And Procedures Will I Have If I Take Part In This Study?|Before You Begin The Study:|Before You Begin The Study:|During The Study:|What Extra Tests And Procedures Will I Have If I Take Part In This Study?|What Extra Tests And Procedures Will I Have If I Take Part In This Study?|Before You Begin The Study:|Before You Begin The Study:

Most of the exams, tests, and procedures you will have are part of the usual approach for your cancer. However, there are some extra tests and procedures that you will need to have if you take part in this study.

Most of the exams, tests, and procedures you will have are part of the usual approach for your cancer. However, there are some extra tests and procedures that you will need to have if you take part in this study.

You will need to have the following extra tests to find out if you can be in the study:  
Pregnancy test (if you are a woman who could have children) EKG (electrocardiogram), a test that checks the electrical activity of your heart Echocardiogram (a sonogram [uses sounds waves] of the heart that allows us to identify any problems with the heart valves or muscle movement.)
Optional biopsy of tumor. This will be further discussed later in the consent.  
PATIENT IDENTIFICATION **Consent to Participate in a Clinical Research Study**  
NIH-2977 (4-17) File in Section 4: Protocol Consent (1) Version Date: 03/03/2020 Page 4 of 17  
CC ICF template v. 09.27.19

You will need to have the following extra tests to find out if you can be in the study:  
Pregnancy test (if you are a woman who could have children)
EKG (electrocardiogram), a test that checks the electrical activity of your heart Echocardiogram (a sonogram [uses sounds waves] of the heart that allows us to identify any problems with the heart valves or muscle movement.)
Optional biopsy of tumor. This will be further discussed later in the consent.  
Echocardiogram will be performed prior to cycles 1 and 2, and then before each scan to evaluate your tumor(s), (i.e. before cycles 3, 5, 7), and repeated more frequently if your doctor thinks it is needed.  
Pregnancy test will be performed before starting treatment and then before each scan to evaluate your tumor(s), (i.e. before cycles 3, 5, 7), if you are a female who can get pregnant.  
Tissue studies (tissue obtained during a previous surgery or biopsy): everyone participating will have tissue requested to study the changes in cell activities of patients with ERMS and ARMS. Your name will not be attached to your tissue; it will be identified using a study number. Only the investigator and research team will have access to the information that links your personal information to your tissue sample.  
Be asked sensitive or private questions which you normally do not discuss May not be able to take part in future studies

EKG will be done before each cycle.  
Echocardiogram will be performed prior to cycles 1 and 2, and then before each scan to evaluate your tumor(s), (i.e. before cycles 3, 5, 7), and repeated more frequently if your doctor thinks it is needed.  
Pregnancy test will be performed before starting treatment and then before each scan to evaluate your tumor(s), (i.e. before cycles 3, 5, 7), if you are a female who can get pregnant.  
Tissue studies (tissue obtained during a previous surgery or biopsy): everyone participating will have tissue requested to study the changes in cell activities of patients with ERMS and ARMS. Your name will not be attached to your tissue; it will be identified using a study number. Only the investigator and research team will have access to the information that links your personal information to your tissue sample.
At the end of treatment with dasatinib-ganitumab you will have an evaluation at the NIH. At this visit you will have a physical exam, blood and urine tests and scans/x-rays to measure your tumor.

Most of the exams, tests, and procedures you will have are part of the usual approach for your cancer. However, there are some extra tests and procedures that you will need to have if you take part in this study.

Most of the exams, tests, and procedures you will have are part of the usual approach for your cancer. However, there are some extra tests and procedures that you will need to have if you take part in this study.

You will need to have the following extra tests to find out if you can be in the study:  
Pregnancy test (if you are a woman who could have children) EKG (electrocardiogram), a test that checks the electrical activity of your heart Echocardiogram (a sonogram [uses sounds waves] of the heart that allows us to identify any problems with the heart valves or muscle movement.)
Optional biopsy of tumor. This will be further discussed later in the consent.  
PATIENT IDENTIFICATION **Consent to Participate in a Clinical Research Study**  
NIH-2977 (4-17) File in Section 4: Protocol Consent (1) Version Date: 03/03/2020 Page 4 of 17  
CC ICF template v. 09.27.19

You will need to have the following extra tests to find out if you can be in the study:  
Pregnancy test (if you are a woman who could have children)
EKG (electrocardiogram), a test that checks the electrical activity of your heart Echocardiogram (a sonogram [uses sounds waves] of the heart that allows us to identify any problems with the heart valves or muscle movement.)
Optional biopsy of tumor. This will be further discussed later in the consent.  
Echocardiogram will be performed prior to cycles 1 and 2, and then before each scan to evaluate your tumor(s), (i.e. before cycles 3, 5, 7), and repeated more frequently if your doctor thinks it is needed.  
Pregnancy test will be performed before starting treatment and then before each scan to evaluate your tumor(s), (i.e. before cycles 3, 5, 7), if you are a female who can get pregnant.  
Tissue studies (tissue obtained during a previous surgery or biopsy): everyone participating will have tissue requested to study the changes in cell activities of patients with ERMS and ARMS. Your name will not be attached to your tissue; it will be identified using a study number. Only the investigator and research team will have access to the information that links your personal information to your tissue sample.  
Be asked sensitive or private questions which you normally do not discuss May not be able to take part in future studies
Clinical trial: NCT03041701
Section: Purpose of Research
Subsections: Patient Identification Consent To Participate In A Clinical Research Study Nih-2977 (4-17) File In Section 4: Protocol Consent (1) Version Date: 03/03/2020 Page 1 Of 17 Cc Icf Template V. 09.27.19 What Is The Usual Approach To My Diagnosis?|Why Is This Study Being Done?|Why Is This Study Being Done?|Why Is This Study Being Done?|Why Is This Study Being Done?

Rhabdomyosarcoma (RMS) is the most common soft tissue sarcoma of childhood. Two major types of RMS are embryonal rhabdomyosarcoma (ERMS) and alveolar rhabdomyosarcoma (ARMS). The treatments for RMS include surgery, radiation therapy or chemotherapy. Some of the agents used to treat rhabdomyosarcoma are approved by the U.S. Food and Drug Administration (FDA) for other indications. New types of treatments being tested in clinical trials include high-dose chemotherapy with stem cell transplant, immunotherapy, or targeted therapy.  
The insulin-like growth factor (IGF) system plays an important role in many cancers. Overexpression of the type 1 IGF receptor (IGF-1R) has been observed in sarcoma. An enzyme called YES is also highly expressed in both ERMS and ARMS. Treatment blocking both IGF and YES appears to slow tumor growth of ERMS and ARMS cells studied in the laboratory. Dasatinib is an enzyme inhibitor that may block over-expression of YES. Dasatinib also appears to have anticancer activity in some cancers. Ganitumab is a monoclonal antibody directed specifically against IGF-1R to suppress tumor growth.

The purposes of this research study are:
1. To find the safe dose of dasatinib when given with ganitumab in patients with ERMS and ARMS.  
2. To assess if the combination of ganitumab and dasatinib is helpful in the treatment of your type of tumor(s) (causes your tumor to shrink or slow down the growth), or can increase survival.  
3. To study the side effects of the combination of ganitumab and dasatinib. 4. To study how ganitumab and dasatinib act on the tumors of people with RMS. 5. To do genomic analysis of tissue samples of patients with ERMS and ARMS (you will be asked to participate in another POB study for this called protocol 10-C-0086:  
PATIENT IDENTIFICATION **Consent to Participate in a Clinical Research Study**  
NIH-2977 (4-17) File in Section 4: Protocol Consent (1) Version Date: 03/03/2020 Page 2 of 17  
CC ICF template v. 09.27.19  
  
  
Comprehensive Omics Analysis of Pediatric Solid Tumors and Establishment of a Repository for Related Biological Studies)
Ganitumab is being used in clinical studies and has been given to adults and children with different types of tumors. Dasatinib was approved by the U.S. Food and Drug Administration (FDA) for treatment of adults with a type of chronic myeloid leukemia (CML). Ganitumab has not been approved by the U.S. Food and Drug Administration (FDA) for any indication. Ganitumab and the combination of ganitumab and dasatinib are experimental, meaning they have not been approved by the FDA, but are approved for use in this clinical trial. Up to 24 evaluable patients may take part in this study.

The purposes of this research study are:  
1. To find the safe dose of dasatinib when given with ganitumab in patients with ERMS and ARMS.  
2. To assess if the combination of ganitumab and dasatinib is helpful in the treatment of your type of tumor(s) (causes your tumor to shrink or slow down the growth), or can increase survival.  
3. To study the side effects of the combination of ganitumab and dasatinib. 4. To study how ganitumab and dasatinib act on the tumors of people with RMS. 5. To do genomic analysis of tissue samples of patients with ERMS and ARMS (you will be asked to participate in another study for this called protocol 10-C-0086: *Comprehensive* Omics Analysis of Pediatric Solid Tumors and Establishment of a Repository for Related Biological Studies)
Ganitumab is being used in clinical studies and has been given to adults and children with different types of tumors. Dasatinib was approved by the U.S. Food and Drug Administration (FDA) for treatment of adults with a type of chronic myeloid leukemia (CML). Ganitumab has not been approved by the U.S. Food and Drug Administration (FDA) for any indication. Ganitumab and the combination of ganitumab and dasatinib are experimental, meaning they have not been approved by the FDA, but are approved for use in this clinical trial. Up to 24 evaluable patients may take part in this study.

The purposes of this research study are:
1. To find the safe dose of dasatinib when given with ganitumab in patients with ERMS and ARMS.  
2. To assess if the combination of ganitumab and dasatinib is helpful in the treatment of your type of tumor(s) (causes your tumor to shrink or slow down the growth), or can increase survival.  
3. To study the side effects of the combination of ganitumab and dasatinib. 4. To study how ganitumab and dasatinib act on the tumors of people with RMS. 5. To do genomic analysis of tissue samples of patients with ERMS and ARMS (you will be asked to participate in another POB study for this called protocol 10-C-0086:  
PATIENT IDENTIFICATION **Consent to Participate in a Clinical Research Study**  
NIH-2977 (4-17) File in Section 4: Protocol Consent (1) Version Date: 03/03/2020 Page 2 of 17  
CC ICF template v. 09.27.19  
  
  
Comprehensive Omics Analysis of Pediatric Solid Tumors and Establishment of a Repository for Related Biological Studies)
Ganitumab is being used in clinical studies and has been given to adults and children with different types of tumors. Dasatinib was approved by the U.S. Food and Drug Administration (FDA) for treatment of adults with a type of chronic myeloid leukemia (CML). Ganitumab has not been approved by the U.S. Food and Drug Administration (FDA) for any indication. Ganitumab and the combination of ganitumab and dasatinib are experimental, meaning they have not been approved by the FDA, but are approved for use in this clinical trial. Up to 24 evaluable patients may take part in this study.

The purposes of this research study are:  
1. To find the safe dose of dasatinib when given with ganitumab in patients with ERMS and ARMS.  
2. To assess if the combination of ganitumab and dasatinib is helpful in the treatment of your type of tumor(s) (causes your tumor to shrink or slow down the growth), or can increase survival.  
3. To study the side effects of the combination of ganitumab and dasatinib. 4. To study how ganitumab and dasatinib act on the tumors of people with RMS. 5. To do genomic analysis of tissue samples of patients with ERMS and ARMS (you will be asked to participate in another study for this called protocol 10-C-0086: *Comprehensive* Omics Analysis of Pediatric Solid Tumors and Establishment of a Repository for Related Biological Studies)
Ganitumab is being used in clinical studies and has been given to adults and children with different types of tumors. Dasatinib was approved by the U.S. Food and Drug Administration (FDA) for treatment of adults with a type of chronic myeloid leukemia (CML). Ganitumab has not been approved by the U.S. Food and Drug Administration (FDA) for any indication. Ganitumab and the combination of ganitumab and dasatinib are experimental, meaning they have not been approved by the FDA, but are approved for use in this clinical trial. Up to 24 evaluable patients may take part in this study.
Clinical trial: NCT03041701
Section: Voluntary Participation
Subsections: It Is Your Choice To Take Part In The Study|My Signature Agreeing To Take Part In The Main Study

You may choose not to take part in this study for any reason. If you join this study, you may change your mind and stop participating in the study at any time and for any reason. In either case, you will not lose any benefits to which you are otherwise entitled. However, to be seen at the NIH, you must be taking part in a study or are being considered for a study. If you do choose to leave the study, please inform your study team to ensure a safe withdrawal from the research.

I have read this consent form or had it read to me. I have discussed it with the study doctor and my questions have been answered. I will be given a signed copy of this form. I agree to take part in the main study and any additional studies where I circled 'yes'. Participant's signature________________________________ Date of signature_____________________________________ Signature of person(s) conducting the informed consent discussion___________________________________ Date of signature_____________________________________
Clinical trial: NCT03041701
Section: Withdrawal from Study
Subsections: Can I Stop Taking Part In This Study?|Can I Stop Taking Part In This Study?|Can I Stop Taking Part In This Study?|Can I Stop Taking Part In This Study?|Can I Stop Taking Part In This Study?|Can I Stop Taking Part In This Study?|Can I Stop Taking Part In This Study?|Can I Stop Taking Part In This Study?|Can I Stop Taking Part In This Study?|What If I Change My Mind?

Yes. You can decide to stop at any time. If you decide to stop for any reason, it is important to let the study doctor know as soon as possible so you can stop safely. If you stop, you can decide whether or not to let the study doctor continue to provide your medical information to the organization helping the investigators to run the study. The study doctor will tell you about new information or changes in the study that may affect your health or your willingness to continue in the study. The study doctor may take you out of the study:  
If your health changes and the study is no longer in your best interest If new information becomes available If you do not follow the study rules If the study is stopped by the sponsor, IRB or FDA.

Yes. You can decide to stop at any time. If you decide to stop for any reason, it is important to let the study doctor know as soon as possible so you can stop safely. If you stop, you can decide whether or not to let the study doctor continue to provide your medical information to the organization running the study. The study doctor will tell you about new information or changes in the study that may affect your health or your willingness to continue in the study. The study doctor may take you out of the study:
If your health changes and the study is no longer in your best interest  
If new information becomes available If you are not able to meet the study requirements for taking selumetinib or keep your appointments If the study is stopped by the sponsor, IRB or FDA. Even though it probably won't happen, it is possible that the manufacturer may not continue to provide the selumetinib to the NCI for some reason. If this would occur, the study will be closed and your study doctor will talk to you about other treatment options (including continuing selumetinib if it becomes commercially available).

Yes. You can decide to stop at any time. If you decide to stop for any reason, it is important to let the study doctor know as soon as possible so you can stop safely. If you stop, you can decide whether or not to let the study doctor continue to provide your medical information to the organization helping the investigators to run the study. The study doctor will tell you about new information or changes in the study that may affect your health or your willingness to continue in the study. The study doctor may take you out of the study:
If your health changes and the study is no longer in your best interest  
If new information becomes available If you do not follow the study rules
If the study is stopped by the sponsor, IRB or FDA.

Yes. You can decide to stop at any time. If you decide to stop for any reason, it is important to let the study doctor know as soon as possible so you can stop safely. If you stop, you can decide whether or not to let the study doctor continue to provide your medical information to the organization helping the investigators to run the study. The study doctor will tell you about new information or changes in the study that may affect your health or your willingness to continue in the study. The study doctor may take you out of the study:  
If your health changes and the study is no longer in your best interest If new information becomes available If you do not follow the study rules If the study is stopped by the sponsor, IRB or FDA.

Yes. You can decide to stop at any time. If you decide to stop for any reason, it is important to let the study doctor know as soon as possible so you can stop safely. If you stop, you can decide whether or not to let the study doctor continue to provide your medical information to the organization running the study. The study doctor will tell you about new information or changes in the study that may affect your health or your willingness to continue in the study. The study doctor may take you out of the study:
If your health changes and the study is no longer in your best interest  
If new information becomes available If you are not able to meet the study requirements for taking selumetinib or keep your appointments If the study is stopped by the sponsor, IRB or FDA. Even though it probably won't happen, it is possible that the manufacturer may not continue to provide the selumetinib to the NCI for some reason. If this would occur, the study will be closed and your study doctor will talk to you about other treatment options (including continuing selumetinib if it becomes commercially available).

Yes. You can decide to stop at any time. If you decide to stop for any reason, it is important to let the study doctor know as soon as possible so you can stop safely. If you stop, you can decide whether or not to let the study doctor continue to provide your medical information to the organization helping the investigators to run the study. The study doctor will tell you about new information or changes in the study that may affect your health or your willingness to continue in the study. The study doctor may take you out of the study:
If your health changes and the study is no longer in your best interest  
If new information becomes available If you do not follow the study rules
If the study is stopped by the sponsor, IRB or FDA.

Yes. You can decide to stop at any time. If you decide to stop for any reason, it is important to let the study doctor know as soon as possible so you can stop safely. If you stop, you can decide whether or not to let the study doctor continue to provide your medical information to the organization helping the investigators to run the study. The study doctor will tell you about new information or changes in the study that may affect your health or your willingness to continue in the study. The study doctor may take you out of the study:  
If your health changes and the study is no longer in your best interest If new information becomes available If you do not follow the study rules If the study is stopped by the sponsor, IRB or FDA.

Yes. You can decide to stop at any time. If you decide to stop for any reason, it is important to let the study doctor know as soon as possible so you can stop safely. If you stop, you can decide whether or not to let the study doctor continue to provide your medical information to the organization running the study. The study doctor will tell you about new information or changes in the study that may affect your health or your willingness to continue in the study. The study doctor may take you out of the study:
If your health changes and the study is no longer in your best interest  
If new information becomes available If you are not able to meet the study requirements for taking selumetinib or keep your appointments If the study is stopped by the sponsor, IRB or FDA. Even though it probably won't happen, it is possible that the manufacturer may not continue to provide the selumetinib to the NCI for some reason. If this would occur, the study will be closed and your study doctor will talk to you about other treatment options (including continuing selumetinib if it becomes commercially available).

Yes. You can decide to stop at any time. If you decide to stop for any reason, it is important to let the study doctor know as soon as possible so you can stop safely. If you stop, you can decide whether or not to let the study doctor continue to provide your medical information to the organization helping the investigators to run the study. The study doctor will tell you about new information or changes in the study that may affect your health or your willingness to continue in the study. The study doctor may take you out of the study:
If your health changes and the study is no longer in your best interest  
If new information becomes available If you do not follow the study rules
If the study is stopped by the sponsor, IRB or FDA.

If you decide now that your specimens and data can be kept for research, you can change your mind at any time. Just contact us (office of ________________________ *(insert name of center)* Institutional Review Board at __________________ *(insert telephone number)*) and let us know that you do not want us to use your specimens and/or data. Then any specimens that remain will be destroyed, and your data will not be used for future research.