Dexrazoxane for Blood Cancer Side Effects

Recruiting in Palo Alto (17 mi)

Overseen by Maro Ohanian

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Active heart disease, Pregnant, Psychiatric illness, others

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well dexrazoxane hydrochloride works in preventing heart-related side effects of chemotherapy in participants with blood cancers, such as acute myeloid leukemia, myelodysplastic syndrome, chronic myeloid leukemia, and myeloproliferative neoplasms. Chemoprotective drugs, such as dexrazoxane hydrochloride, may protect the heart from the side effects of drugs used in chemotherapy, such as cladribine, idarubicin, cytarabine, and gemtuzumab ozogamicin, in participants with blood cancers.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

How does the drug dexrazoxane differ from other treatments for blood cancer side effects?

Dexrazoxane is unique because it is specifically used to protect the heart from damage caused by anthracycline chemotherapy, which is a common treatment for various cancers. Unlike other treatments that may focus on directly targeting cancer cells, dexrazoxane works by preventing heart damage without affecting the cancer-fighting effectiveness of the chemotherapy. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults with certain blood cancers like acute myeloid leukemia or chronic myeloid leukemia, who haven't had more than three cycles of chemotherapy. They should have a heart function test showing normal results and agree to use contraception. It's not for those with severe heart disease, recent heart attacks, uncontrolled psychiatric illness, known allergies to the drugs used in the study, or women who are pregnant or breastfeeding.

Inclusion Criteria

My blood cancer is in an advanced stage.

My cancer is a type of leukemia affecting areas outside the bone marrow.

I have an active brain or spinal cord condition.

Exclusion Criteria

Any condition, including the presence of laboratory abnormalities, which judged by the investigator, places the patient at unacceptable risk

I have not had a recent heart attack or severe heart issues in the last 6 months.

I have a serious heart valve problem.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants receive gemtuzumab ozogamicin, cladribine, dexrazoxane hydrochloride, idarubicin, and cytarabine. Treatment repeats every 3-7 weeks for up to 2 courses.

6 months

Consolidation

Participants receive gemtuzumab ozogamicin, cladribine, dexrazoxane hydrochloride, idarubicin, and cytarabine. Treatment repeats every 3-7 weeks for up to 6 courses.

6 months

Maintenance

Participants in remission receive gemtuzumab ozogamicin, dexrazoxane hydrochloride, idarubicin, and cytarabine. Courses repeat every 3-7 weeks for 32 months.

32 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6-12 months

Treatment Details

Interventions

• Dexrazoxane Hydrochloride (Cardioprotective Agent)

Trial Overview The trial is testing dexrazoxane hydrochloride's ability to prevent heart damage from chemotherapy in patients with various blood cancers. Participants will receive standard chemo drugs along with dexrazoxane to see if it reduces cardiac side effects compared to usual care without dexrazoxane.

Participant Groups

Group I: Supportive care (dexrazoxane hydrochloride, chemotherapy) Experimental Treatment 5 Interventions

See detailed description.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

M D Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center Lead Sponsor

National Cancer Institute (NCI) Collaborator

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Dexrazoxane : a review of its use for cardioprotection during anthracycline chemotherapy. [2018] Dexrazoxane (Cardioxane, Zinecard, a cyclic derivative of edetic acid, is a site-specific cardioprotective agent that effectively protects against anthracycline-induced cardiac toxicity. Dexrazoxane is approved in the US and some European countries for cardioprotection in women with advanced and/or metastatic breast cancer receiving doxorubicin; in other countries dexrazoxane is approved for use in a wider range of patients with advanced cancer receiving anthracyclines. As shown in clinical trials, intravenous dexrazoxane significantly reduces the incidence of anthracycline-induced congestive heart failure (CHF) and adverse cardiac events in women with advanced breast cancer or adults with soft tissue sarcomas or small-cell lung cancer, regardless of whether the drug is given before the first dose of anthracycline or the administration is delayed until cumulative doxorubicin dose is > or =300 mg/m2. The drug also appears to offer cardioprotection irrespective of pre-existing cardiac risk factors. Importantly, the antitumour efficacy of anthracyclines is unlikely to be altered by dexrazoxane use, although the drug has not been shown to improve progression-free and overall patient survival. At present, the cardioprotective efficacy of dexrazoxane in patients with childhood malignancies is supported by limited data. The drug is generally well tolerated and has a tolerability profile similar to that of placebo in cancer patients undergoing anthracycline-based chemotherapy, with the exception of a higher incidence of severe leukopenia (78% vs 68%; p

2. Netherlands pubmed.ncbi.nlm.nih.gov

Cardioprotective effect of dexrazoxane in a rat model of myocardial infarction: anti-apoptosis and promoting angiogenesis. [2013] Dexrazoxane (DZR) is a clinically approved agent for preventive treatment of doxorubicin-induced cardiotoxicity. The objective of this study was to investigate the cardioprotective effects of DZR in a rat model of myocardial infarction (MI).

3. Germany pubmed.ncbi.nlm.nih.gov

Late anthracycline cardiotoxicity protection by dexrazoxane (ICRF-187) in pediatric patients: echocardiographic follow-up. [2018] The authors conducted a retrospective study to determine whether dexrazoxane (ICRF-187) would reduce late anthracycline-induced cardiotoxicity in patients treated in childhood for hematological malignancy.

4. Germany pubmed.ncbi.nlm.nih.gov

Protection against doxorubicin-induced cardiotoxicity in weanling rats by dexrazoxane. [2013] Dexrazoxane (DZR) protects against anthracycline-induced cardiotoxicity in several laboratory animal species and in patients with breast cancer. Encouraging results have also been obtained in a limited number of pediatric oncology patients. We conducted studies to determine the safety and cardioprotective activity of DZR in the doxorubicin (DOX)-treated weanling rat simulating the rapidly growing immature child.

5. Hungary pubmed.ncbi.nlm.nih.gov

[Subacute cardiotoxicity caused by anthracycline therapy in children: can dexrazoxane prevent this effect?]. [2013] The use of anthracyclines are limited by their cardiotoxic side effects (first of all congestive cardiomyopathy). In this study we analyzed the anthracycline-induced cardiotoxicity and the possible preventive role of dexrazoxane in children.