Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003718
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
1999-11-01
Brief Title:
Temozolomide in Treating Patients With Advanced Soft Tissue Sarcoma
Sponsor:
Herbert Irving Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Evaluation of Temodal Temozolomide Schering in Previously Treated Advanced Sarcomas
Status:
UNKNOWN
Status Verified Date:
2001-08
Last Known Status:
ACTIVE_NOT_RECRUITING
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 cancer cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of temozolomide in treating patients who have advanced soft tissue sarcoma
PURPOSE Phase II trial to study the effectiveness of temozolomide in treating patients who have advanced soft tissue sarcoma
Detailed Description:
OBJECTIVES I Determine the efficacy as measured by the response rate of temozolomide in patients with unresectable stage IV or recurrent soft tissue sarcoma who have failed no more than 2 prior treatment regimens II Determine the clinical and laboratory toxicities as well as patient tolerance of this regimen in this patient population
OUTLINE Patients are stratified according to ECOG performance status 0-1 vs 2 prior surgery yes vs no prior radiotherapy yes vs no and prior chemotherapy regimens 0 vs 1 vs 2 Patients receive oral temozolomide every 12 hours for 5 days Courses repeat every 4 weeks for at least 18 months in the absence of unacceptable toxicity or disease progression Patients are followed every 3 months for the first 18 months every 6 months for the next 18 months and then annually thereafter until death
PROJECTED ACCRUAL A total of 15-25 patients will be accrued for this study
OUTLINE Patients are stratified according to ECOG performance status 0-1 vs 2 prior surgery yes vs no prior radiotherapy yes vs no and prior chemotherapy regimens 0 vs 1 vs 2 Patients receive oral temozolomide every 12 hours for 5 days Courses repeat every 4 weeks for at least 18 months in the absence of unacceptable toxicity or disease progression Patients are followed every 3 months for the first 18 months every 6 months for the next 18 months and then annually thereafter until death
PROJECTED ACCRUAL A total of 15-25 patients will be accrued for this study
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-V98-1510 | None | None | None |
| CPMC-IRB-8358 | None | None | None |