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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 up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 20 Other Conditions
No Placebo-Only Group
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
13,928 Previous Clinical Trials
41,018,121 Total Patients Enrolled
Susan RheingoldPrincipal InvestigatorChildren's Oncology Group
1 Previous Clinical Trials
13 Total Patients Enrolled
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