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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase II Trial of Rebeccamycin Analogue (NSC #655649) in Children With Solid Tumors

Conditions
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Brain and Central Nervous System Tumors, Lymphoma, Neuroblastoma, Retinoblastoma, Sarcoma, Unspecified Childhood Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: becatecarin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>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. | Drug: becatecarin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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childhood infratentorial ependymoma, recurrent childhood rhabdomyosarcoma, childhood supratentorial ependymoma, childhood craniopharyngioma, disseminated neuroblastoma, recurrent neuroblastoma, intraocular retinoblastoma, extraocular retinoblastoma, stage III childhood lymphoblastic lymphoma, stage IV childhood lymphoblastic lymphoma, recurrent childhood lymphoblastic lymphoma, childhood central nervous system germ cell tumor, unspecified childhood solid tumor, protocol specific, childhood high-grade cerebral astrocytoma, childhood oligodendroglioma, childhood choroid plexus tumor, childhood grade I meningioma, childhood grade II meningioma, childhood grade III meningioma, stage III childhood large cell lymphoma, stage IV childhood small noncleaved cell lymphoma, stage IV childhood large cell lymphoma, recurrent childhood small noncleaved cell lymphoma, recurrent childhood large cell lymphoma, recurrent childhood brain stem glioma, recurrent childhood supratentorial primitive neuroectodermal tumor, recurrent childhood cerebellar astrocytoma, recurrent childhood cerebral astrocytoma, recurrent childhood medulloblastoma, recurrent childhood visual pathway and hypothalamic glioma, previously treated childhood rhabdomyosarcoma, recurrent childhood ependymoma, recurrent retinoblastoma