Rebeccamycin Analog in Treating Children With Relapsed or Refractory Neuroblastoma

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00003737

Enrollment

Registered

2003-01-27

Start date

1999-01-31

Completion date

2006-09-30

Last updated

2013-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroblastoma

Keywords

recurrent neuroblastoma

Brief summary

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

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.

Interventions

DRUGbecatecarin

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Response (complete response, very good partial response, or partial response)	—
Freedom from progression	—
Time to treatment failure	—

Secondary

Measure	Time frame
Toxicity	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026