Rebeccamycin Analog in Treating Children With Relapsed or Refractory Neuroblastoma
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|ClinicalTrials.gov Identifier: NCT00003737|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 25, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma||Drug: becatecarin||Phase 2|
- 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 (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Official Title:||A Pharmacokinetic-Guided Phase II Trial of the Rebeccamycin Analog NSC# 655649 in Pediatric Patients With Relapsed/Refractory Neuroblastoma|
|Study Start Date :||January 1999|
|Primary Completion Date :||September 2006|
|Study Completion Date :||September 2006|
- Response (complete response, very good partial response, or partial response)
- Freedom from progression
- Time to treatment failure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|