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Alkylating agent

Treatment (Oblimersen sodium, cytotoxic chemotherapy) for Cardiac Toxicity

Phase 1
Waitlist Available
Led By Susan Rheingold
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1 (pre-infusion), 5, 6, and 8 (end of infusion)
Awards & highlights

Summary

Phase I trial to study the effectiveness of oblimersen plus combination chemotherapy and dexrazoxane in treating children and adolescents who have relapsed or refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of doxorubicin and cyclophosphamide by making the tumor cells more sensitive to the drug. Chemoprotective drugs such as dexrazoxane may protect normal cells from the side effects of chemotherapy

Eligible Conditions
  • Cardiac Toxicity
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1 (pre-infusion), 5, 6, and 8 (end of infusion)
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1 (pre-infusion), 5, 6, and 8 (end of infusion) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Antitumor activity
Biologic activity of oblimersen in mononuclear cells and tumor tissues, in terms of B-cell lymphoma 2 (bcl-2) and related protein expression
Change in pharmacokinetic behavior of this regimen
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (Oblimersen sodium, cytotoxic chemotherapy)Experimental Treatment7 Interventions
See detailed description.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
oblimersen sodium
2003
Completed Phase 3
~990
Dexrazoxane
FDA approved
Doxorubicin
FDA approved
Cyclophosphamide
FDA approved
Filgrastim
FDA approved

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,748 Previous Clinical Trials
40,959,386 Total Patients Enrolled
Susan RheingoldPrincipal InvestigatorChildren's Oncology Group
1 Previous Clinical Trials
13 Total Patients Enrolled
~1 spots leftby Sep 2025
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