Rebeccamycin Analog in Treating Children With Relapsed or Refractory Neuroblastoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-01-31

Study Completion Date

2006-09-30

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.

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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.

Conditions

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Neuroblastoma

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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becatecarin

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No