Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
Study NCT ID:
NCT00024258
Status:
COMPLETED
Last Update Posted:
2015-11-25
First Post:
2001-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Arsenic Trioxide in Treating Patients With Advanced Neuroblastoma or Other Childhood Solid Tumors
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Study Overview
Official Title:
Phase II Study of Arsenic Trioxide in Neuroblastoma and Other Pediatric Solid Tumors
Status:
COMPLETED
Status Verified Date:
2015-10
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 arsenic trioxide in treating children who have advanced neuroblastoma or other solid tumors.
PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating children who have advanced neuroblastoma or other solid tumors.
Detailed Description:
OBJECTIVES:
* Determine the response rates of patients with advanced neuroblastoma or other pediatric solid tumors treated with arsenic trioxide.
* Determine the toxicity of this drug in these patients.
OUTLINE: Patients are stratified according to type of disease (neuroblastoma with progressive disease vs neuroblastoma with stable refractory disease vs other solid tumor).
Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2-3 months for 1 year and then annually thereafter.
* Determine the response rates of patients with advanced neuroblastoma or other pediatric solid tumors treated with arsenic trioxide.
* Determine the toxicity of this drug in these patients.
OUTLINE: Patients are stratified according to type of disease (neuroblastoma with progressive disease vs neuroblastoma with stable refractory disease vs other solid tumor).
Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2-3 months for 1 year and then annually thereafter.
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 ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA008748 | NIH | None | https://reporter.nih.gov/quic… | View |
| MSKCC-01042 | None | None | View | |
| CTI-1059 | None | None | View | |
| NCI-G01-2014 | None | None | View |