Rebeccamycin Analog in Treating Children With Relapsed or Refractory Neuroblastoma

Memorial Sloan Kettering Cancer Center30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Neuroblastoma

Interventions

becatecarinDRUG

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Outcomes

Primary Outcomes

Response (complete response, very good partial response, or partial response)

Freedom from progression

Time to treatment failure

Secondary Outcomes

Toxicity

Data from ClinicalTrials.gov

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