Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024258
Status:
COMPLETED
Last Update Posted:
2015-11-25
First Post:
2001-09-13
Brief Title:
Arsenic Trioxide in Treating Patients With Advanced Neuroblastoma or Other Childhood Solid Tumors
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G01-2014 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA008748 |
| P30CA008748 | NIH | None | None |
| MSKCC-01042 | None | None | None |
| CTI-1059 | None | None | None |