Rebeccamycin Analogue in Treating Children With Solid Tumors or Non-Hodgkin's Lymphoma

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.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed solid tumors

• Neuroblastoma
• Ewing's sarcoma/peripheral primitive neuroectodermal tumor (PNET)(Ewing's sarcoma closed to accrual as of 5/19/03)
• Osteosarcoma (closed to accrual as of 5/19/03)
• Rhabdomyosarcoma
• Other extracranial solid tumors
• CNS/brain tumors:

• Medulloblastoma/PNET
• Ependymoma
• Brainstem glioma
• Other CNS tumors
• Histological verification may be waived for brainstem glioma and classic optic glioma, but biopsy recommended OR
• Histologically or cytologically proven non-Hodgkin's lymphoma

• Refractory to standard treatment and no curative therapy available
• Measurable disease

PATIENT CHARACTERISTICS:

Age:

• 21 and under at time of original diagnosis

Performance status:

• Karnofsky 50-100% in patients over 10 years of age
• Lansky 50-100% in patients age 10 and under

Life expectancy:

• At least 8 weeks

Hematopoietic:

• Absolute neutrophil count greater than 1,000/mm^3
• Platelet count greater than 75,000/mm^3
• Hemoglobin greater than 8.0 g/dL

Hepatic:

• Bilirubin normal for age
• SGPT less than 2.5 times upper limit of normal
• Amylase normal
• Lipase normal

Renal:

• Creatinine normal for age OR
• Glomerular filtration rate at least 60 mL/min

Other:

• No concurrent uncontrolled infection
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 6 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Recovered from prior immunotherapy

Chemotherapy:

• At least 6 weeks since prior nitrosourea and recovered
• Recovered from any other prior chemotherapy
• No more than two prior chemotherapy regimens

Endocrine therapy:

• CNS tumor patients receiving dexamethasone must be on stable or decreasing dose at least 2 weeks prior to study entry

Radiotherapy:

• At least 6 weeks since prior extended radiotherapy and recovered
• No prior total body irradiation

Surgery:

• Prior radiosurgery allowed

Other:

• No concurrent use of the following foods or medications:

• Grapefruit juice
• Erythromycin
• Azithromycin
• Clarithromycin
• Rifampin and analogues
• Fluconazole
• Ketoconazole
• Itraconazole
• Cimetidine
• Cannabinoids (marijuana or dronabinol)
• Leukotriene inhibitors (e.g., zafirlukast and zileuton)
• No other concurrent anticancer or investigational agents