Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00003737


Primary Contact:

Study Chair
Tanya Trippett, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

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