Rebeccamycin Analog in Treating Children With Relapsed or Refractory Neuroblastoma

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of rebeccamycin analog in treating children who have relapsed or refractory neuroblastoma.

Detailed Description
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OBJECTIVES: Determine the response rate to rebeccamycin analogue in children with relapsed or refractory neuroblastoma. Determine the toxicity of this drug in these patients. Identify and establish in vitro biologic correlates of clinical responses and toxicity of this drug in these patients. OUTLINE: Patients receive rebeccamycin analogue IV over 1 hour once on days 1-5. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: This study will accrue up to 30 patients within 1.5 years.

Official Title
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A Pharmacokinetic-Guided Phase II Trial of the Rebeccamycin Analog NSC# 655649 in Pediatric Patients With Relapsed/Refractory Neuroblastoma

Conditions
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Neuroblastoma

Intervention / Treatment
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* Drug: becatecarin


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically proven relapsed or refractory neuroblastoma Measurable disease PATIENT CHARACTERISTICS: Age: Children Performance status: ECOG 0-2 Life expectancy: At least 2 months Hematopoietic: Not specified Hepatic: Bilirubin less than 1.5 mg/dL SGOT and SGPT less than 2.5 times upper limit of normal (ULN) Adequate liver function unless due to disease Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance at least 60 mL/min Adequate renal function unless due to disease Other: No other serious concurrent illness No active uncontrolled infection Not pregnant Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Recovered from prior immunotherapy Prior autologous bone marrow transplantation allowed No concurrent immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy and recovered No other concurrent systemic chemotherapy Endocrine therapy: Not specified Radiotherapy: Recovered from prior radiotherapy Surgery: Not specified

Ages Eligible for Study
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Maximum Age: 18 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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: becatecarin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response (complete response, very good partial response, or partial response) |  |  | 
| Freedom from progression |  |  | 
| Time to treatment failure |  |  | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent neuroblastoma