Carvedilol for Preventing Heart Failure in Childhood Cancer Survivors

Recruiting at 94 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Children's Oncology Group

Must not be taking: Beta blockers, CYP2D6 inhibitors

Disqualifiers: Cardiomyopathy, Hypertension, Asthma, Diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 24 months

196 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase IIb trial studies how well low-dose carvedilol works in preventing heart failure in cancer survivors exposed to high dose anthracyclines for management of childhood cancer. Patients who received high-dose anthracycline chemotherapy are at a much greater risk for developing heart failure compared to survivors who didn't get any anthracycline chemotherapy. Heart failure happens when the heart muscle has been weakened and can't pump blood as well as it should. Carvedilol may help lower the risk of cardiovascular complications.

Research Team

Saro H Armenian

Principal Investigator

Children's Oncology Group

Eligibility Criteria

This trial is for childhood cancer survivors who are now at risk of heart failure due to high-dose anthracycline chemotherapy. Participants must weigh at least 40 Kg, have been diagnosed with cancer before age 22, finished treatment at least 2 years ago, and received a certain amount of anthracycline without dexrazoxane protection.

Inclusion Criteria

I received a high dose of a specific chemotherapy drug for cancer treated before I was 22.

I was diagnosed with cancer before turning 22.

I weigh at least 40 kg.

Exclusion Criteria

Your blood doesn't have enough red cells.

I don't have stomach or liver problems affecting medication absorption.

My hormone-related condition is not controlled by medication.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive low-dose carvedilol or placebo orally once or twice daily for 24 months

24 months

Regular visits at baseline, 6 months, 12 months, 18 months, and 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Treatment Details

Interventions

• Carvedilol

Trial Overview The study tests if low-dose Carvedilol can prevent heart failure in those exposed to high doses of anthracyclines during childhood cancer treatment. It includes lab biomarker analysis, pharmacogenomic and pharmacological studies, placebo comparison, quality-of-life assessment, and questionnaires.

Participant Groups

Group I: Arm I (carvedilol) Experimental Treatment 6 Interventions

Patients receive low-dose carvedilol PO QD or BID for 24 months.

Group II: Arm II (placebo) Placebo Group 6 Interventions

Patients receive placebo PO QD or BID for 24 months.

Carvedilol is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Coreg for:

• Hypertension
• Heart failure
• Left ventricular dysfunction following myocardial infarction

Approved in European Union as Dilatrend for:

• Hypertension
• Heart failure
• Left ventricular dysfunction following myocardial infarction

Approved in Canada as Eucardic for:

• Hypertension
• Heart failure
• Left ventricular dysfunction following myocardial infarction

Approved in Japan as Carloc for:

• Hypertension
• Heart failure
• Left ventricular dysfunction following myocardial infarction

Who Is Running the Clinical Trial?

Children's Oncology Group

Lead Sponsor

Trials

467

Recruited

241,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+