Introduction

This summary is intended to provide a general overview of the Children's Oncology Group (COG) study ALTE1621. It will provide information about the children who are eligible for this study and basic information regarding the specifics of the study. The informed consent and protocol contain the full details of the study. Those documents are available to you from your oncologist.

It is important to understand that participating in a clinical trial is entirely voluntary. The decision about whether or not to participate will not affect the care provided by the health care team in any way. You can find additional information about participation in clinical trials at www.childrensoncologygroup.org. Always discuss any questions that you may have with your health care team.

Study Number

ALTE1621

Official Title

ALTE1621 Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Heart Failure (PREVENT-HF): A Phase 2b Randomized Placebo-Controlled (Carvedilol) Trial

Trial Opening Date

ALTE1621 opened on April 4, 2016. This study will allow 250 people to participate. This study does not have a set end date.

General Patient Eligibility

Patients are eligible to participate in this study if they:

• Weigh at least 88lbs (40Kg)
• Have a cancer diagnosis before 21 years of age
• Have received chemotherapy with a high dose of anthracyclines
  • Examples of anthracyclines include: Adriamycin (Doxorubicin), Daunomycin (Daunorubicin), Epirubicin, Mitoxantrone (Novantrone) and Idarubicin
  • Have completed cancer treatment at least 2 years prior to study participation

Please consult your doctor to determine whether your child may participate in this study.

General Background and Study Goal

Many forms of childhood cancer are treated with a class of chemotherapy drugs called anthracyclines. This kind of chemotherapy has improved survival rates of certain childhood cancesr. However, with long-term follow-up, we now understand that people who received anthracyclines at a young age have a much higher risk for developing heart problems, such as congestive heart failure, compared to survivors who did not get anthracyclines. Congestive heart failure is a weakness of the heart muscle that causes fluid to build up in the lungs and other body tissues.

Researchers are investigating if taking carvedilol for 2 years can help lower the risk of developing congestive heart failure in patients who had cancer at age 21 or younger and were treated with anthracyclines.

Carvedilol is a medicine that has been used to treat heart failure for many years. It is also used to treat high blood pressure and to prevent heart failure in people with high blood pressure. The main risks of taking carvedilol are dizziness, slow heart rate and fatigue. These are more common with higher doses of carvedilol and in people who already have symptoms of heart failure.

Summary of the Treatment

Patients who wish to participate in this study will have a physical exam, EKG, echocardiogram (ultrasound of the heart) and blood tests to see if they are eligible to be in the study. Patients who are able to be in the study will be given pills containing either a placebo (sugar pill) or carvedilol to take every day for 2 years.

Patients will come back to the clinic in 2 weeks, 6 weeks and 3 months after starting the medicine for a physical exam and EKG.

Patients will come back to the clinic every 6 months for a physical exam, echocardiogram (ultrasound of the heart), blood tests and to answer some questions about how you feel during the study.

Risks and Side Effects

All risks and side effects will be explained by your study team during the consent process. They can answer any questions that you may have about giving permission for your child to be in the study.

The study consent form has more details about possible risks and side effects of this study.

Contact Information

Your child's oncologist and nurses are the best sources for further information

Study Chair

Saro Armenian, DO, MPH
City of Hope

FAMILY PROTOCOL SUMMARY REVIEW/APPROVALS