Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003737
Status:
COMPLETED
Last Update Posted:
2013-06-25
First Post:
1999-11-01
Brief Title:
Rebeccamycin Analog in Treating Children With Relapsed or Refractory Neuroblastoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Pharmacokinetic-Guided Phase II Trial of the Rebeccamycin Analog NSC 655649 in Pediatric Patients With RelapsedRefractory Neuroblastoma
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 15 years
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 15 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-T98-0041 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066852 | REGISTRY | None | None |