Dexrazoxane for Blood Cancer Side Effects

Overseen By Maro Ohanian

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

Trial Summary

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}

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.

Research Team

Maro Ohanian

Principal Investigator

M.D. Anderson Cancer Center

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.

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

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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Dexrazoxane is an effective cardioprotective agent that significantly reduces the risk of anthracycline-induced congestive heart failure and other cardiac events in cancer patients, particularly in women with advanced breast cancer and adults with soft tissue sarcomas or small-cell lung cancer.

The use of dexrazoxane does not appear to affect the antitumor efficacy of anthracyclines, making it a valuable option for preventing cardiotoxicity without compromising cancer treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexrazoxane : a review of its use for cardioprotection during anthracycline chemotherapy. Cvetković, RS., Scott, LJ.[2018]

In a study involving Sprague-Dawley rats, dexrazoxane (DZR) significantly reduced infarct size and improved cardiac function after myocardial infarction, indicating its cardioprotective effects.

DZR treatment was associated with increased capillary density and bone marrow-derived endothelial progenitor cells, suggesting that its mechanism of action may involve promoting neovascularization and reducing apoptosis in heart tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardioprotective effect of dexrazoxane in a rat model of myocardial infarction: anti-apoptosis and promoting angiogenesis. Zhou, L., Sung, RY., Li, K., et al.[2013]

In a study of 108 childhood cancer survivors, dexrazoxane significantly reduced the risk of late anthracycline-induced cardiotoxicity, with only 5% of patients receiving cardioprotection showing a decline in heart function compared to 15% in those without it.

The use of dexrazoxane did not negatively impact chemotherapy response rates or overall survival, indicating it is a safe option for protecting heart health in young patients treated for hematological malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Late anthracycline cardiotoxicity protection by dexrazoxane (ICRF-187) in pediatric patients: echocardiographic follow-up. Elbl, L., Hrstkova, H., Tomaskova, I., et al.[2018]

Dexrazoxane (DZR) effectively protects against doxorubicin (DOX)-induced cardiotoxicity in both young and mature rats, showing significant cardioprotective activity at all time points examined during the study.

The study demonstrated that DZR mitigates adverse effects on liver and kidney weights, as well as serum cholesterol and triglycerides, indicating its potential safety and efficacy in reducing the harmful side effects of DOX treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protection against doxorubicin-induced cardiotoxicity in weanling rats by dexrazoxane. Della Torre, P., Mazué, G., Podestà, A., et al.[2013]

In a study of 158 children treated with anthracyclines, the use of dexrazoxane was associated with a lower incidence of reduced left ventricular function, showing a significant protective effect over time, especially 5 years post-therapy (2.4% in the dexrazoxane group vs. 11.0% in the control group).

Dexrazoxane appears to significantly reduce the risk of anthracycline-induced cardiotoxicity, as indicated by a decrease in abnormal left ventricular function and wall diameter, although longer follow-up is needed for definitive conclusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Subacute cardiotoxicity caused by anthracycline therapy in children: can dexrazoxane prevent this effect?]. Erlaky, H., Tóth, K., Szabolcs, J., et al.[2013]

References

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

Dexrazoxane : a review of its use for cardioprotection during anthracycline chemotherapy. [2018]

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

Cardioprotective effect of dexrazoxane in a rat model of myocardial infarction: anti-apoptosis and promoting angiogenesis. [2013]

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

Late anthracycline cardiotoxicity protection by dexrazoxane (ICRF-187) in pediatric patients: echocardiographic follow-up. [2018]

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

Protection against doxorubicin-induced cardiotoxicity in weanling rats by dexrazoxane. [2013]

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

[Subacute cardiotoxicity caused by anthracycline therapy in children: can dexrazoxane prevent this effect?]. [2013]