Rebeccamycin Analog in Treating Children With Relapsed or Refractory Neuroblastoma
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 Design:||Primary Purpose: Treatment|
|Official Title:||A Pharmacokinetic-Guided Phase II Trial of the Rebeccamycin Analog NSC# 655649 in Pediatric Patients With Relapsed/Refractory Neuroblastoma|
- Response (complete response, very good partial response, or partial response) [ Designated as safety issue: No ]
- Freedom from progression [ Designated as safety issue: No ]
- Time to treatment failure [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
|Study Start Date:||January 1999|
|Study Completion Date:||September 2006|
|Primary Completion Date:||September 2006 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003737
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Tanya Trippett, MD||Memorial Sloan Kettering Cancer Center|