Oblimersen Plus Combination Chemotherapy and Dexrazoxane in Treating Children and Adolescents With Relapsed or Refractory Solid Tumors

Completed · Phase 1

Conditions studied: Cardiac Toxicity, Unspecified Childhood Solid Tumor, Protocol Specific

In brief

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

Key facts

Study ID

NCT00039481

Run by

National Cancer Institute (NCI)

People needed

15

Starts

2002-11-01

Last updated by the study team

2013-01-17

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed solid tumor at original diagnosis that has failed standard therapy or for which no standard therapy exists
• Patients must have a disease for which there is no known curative potential
• Patients must meet the following criteria for bone marrow function:
• Status post stem cell transplantation (SCT)
• Absolute neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3 (transfusion independent)
• Hemoglobin at least 8.0 g/dL (RBC transfusions allowed)
• No lymphomas
• No CNS tumors or known metastatic disease to the brain or spinal cord
• Performance status - Karnofsky 50-100% (age 11 to 21)
• Performance status - Lansky 50-100% (age 1 to 10)
• At least 8 weeks
• See Disease Characteristics
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• ALT no greater than 3 times ULN
• No significant hepatic dysfunction
• Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
• Creatinine, based on age, as follows:
• Age 1 to 5: no greater than 0.8 mg/dL
• Age 6 to 10: no greater than 1.0 mg/dL
• Age 11 to 15: no greater than 1.2 mg/dL
• Age 16 to 21: no greater than 1.5 mg/dL
• No significant renal dysfunction
• Shortening fraction at least 28% by echocardiogram
• Ejection fraction at least 45% by MUGA

Where it is running

• Children's Oncology Group — Arcadia, California, United States

Full record on ClinicalTrials.gov

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