Oblimersen Plus Combination Chemotherapy and Dexrazoxane in Treating Children and Adolescents With Relapsed or Refractory Solid Tumors
Cardiac Toxicity, Unspecified Childhood Solid Tumor, Protocol Specific
About this trial
This is an interventional treatment trial for Cardiac Toxicity
Eligibility Criteria
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
Sites / Locations
- Children's Oncology Group
Arms of the Study
Arm 1
Experimental
Treatment (Oblimersen sodium, cytotoxic chemotherapy)
See detailed description.