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This Phase 1 trial by the National Cancer Institute (NCI) studied the effectiveness of oblimersen sodium (G3139, a bcl-2 antisense oligodeoxynucleotide, Genasense) plus combination chemotherapy and dexrazoxane in children and adolescents with relapsed or refractory solid tumors. Oblimersen may increase the effectiveness of doxorubicin and cyclophosphamide by making tumor cells more sensitive to the drugs, while chemoprotective drugs such as dexrazoxane may protect normal cells from chemotherapy side effects. Eligible patients had a histologically confirmed solid tumor at original diagnosis that had failed standard therapy or for which no standard therapy exists, with no known curative potential; the trial is completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * 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 * No significant pulmonary dysfunction * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No serious uncontrolled infections * No other end-organ dysfunction that would preclude study entry * No other clinically significant systemic illness * See Disease Characteristics * Recovered from prior immunotherapy * At least 1 week since prior growth factors or other biologic agents * At least 6 months since prior autologous SCT * At least 6 months since prior allogeneic bone marrow transplantation and recovered with no evidence of graft-versus-host disease * No concurrent immunomodulating agents * No concurrent prophylactic growth factors during the first course of the study * No concurrent immunotherapy or other biologic therapy * Recovered from prior chemotherapy * At least 2 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) * No prior life-time cumulative doxorubicin dose of more than 450 mg/m\^2 or equivalent * No other concurrent chemotherapy * Concurrent chronic steroids allowed * Recovered from prior radiotherapy * More than 2 weeks since prior localized palliative radiotherapy (small port) * More than 6 months since prior substantial radiotherapy to bone marrow (craniospinal radiotherapy, total body irradiation, or hemi-pelvic radiotherapy) * No concurrent radiotherapy * Concurrent chronic medications (e.g., narcotics or antiepileptics) allowed * No other concurrent investigational agents * No other concurrent cancer therapy