Phase II trial to study the effectiveness of rebeccamycin analogue in treating children who have solid tumors or non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
OBJECTIVES: I. Determine the response in children with solid tumors or non-Hodgkin's lymphoma treated with rebeccamycin analogue. II. Determine and maintain a plasma concentration of at least 5 µg/mL of this drug in these patients. III. Determine the toxicity of this drug in these patients. IV. Determine the pharmacokinetics of this drug in these patients. OUTLINE: This is a multicenter study. Patients with solid tumors are stratified according to tumor histology (neuroblastoma vs Ewing's sarcoma \[closed to accrual as of 5/19/03\]/peripheral primative neuroectodermal tumor \[PNET\] vs osteosarcoma \[closed to accrual as of 5/19/03\] vs rhabdomyosarcoma vs non-Hodgkin's lymphoma vs other solid tumors). Patients with CNS tumors are stratified according to tumor histology (medulloblastoma/PNET vs ependymoma vs brainstem glioma vs other CNS tumors). Patients receive rebeccamycin analogue IV over 1 hour on day 1. Treatment continues every 21 days for a total of 16 courses in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 1 year, every 2 months for 2 years, every 6 months for 1 year, and then annually thereafter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
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