Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005069
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2000-04-06
Brief Title:
Arsenic Trioxide in Treating Patients With Metastatic Kidney Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Trial of Arsenic Trioxide NSC 706363 in Patients With Advanced Renal Cell Carcinoma
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 arsenic trioxide in treating patients who have metastatic kidney cancer
PURPOSE Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have metastatic kidney cancer
Detailed Description:
OBJECTIVES I Evaluate the efficacy of arsenic trioxide in patients with metastatic renal cell cancer II Determine the safety of this regimen in this patient population
OUTLINE Patients receive arsenic trioxide IV over 1-4 hours daily for 5 days Treatment continues every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity Patients are followed for at least 1 month
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within 6-19 months
OUTLINE Patients receive arsenic trioxide IV over 1-4 hours daily for 5 days Treatment continues every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity Patients are followed for at least 1 month
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within 6-19 months
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 |
|---|---|---|---|
| CDR0000067674 | REGISTRY | None | None |
| NCI-T99-0105 | Registry Identifier | PDQ Physician Data Query | None |