Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005066
Status:
COMPLETED
Last Update Posted:
2013-09-05
First Post:
2000-04-06
Brief Title:
O6-benzylguanine and Carmustine in Treating Patients With Recurrent Metastatic or Locally Advanced Soft Tissue Sarcoma
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
A Phase II Trial of O6-Benzylguanine NSC 637037 and BCNU Carmustine in Patients With Advanced Soft Tissue Sarcoma
Status:
COMPLETED
Status Verified Date:
2013-09
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining O6-benzylguanine and carmustine in treating patients who have recurrent metastatic or locally advanced soft tissue sarcoma
PURPOSE Phase II trial to study the effectiveness of combining O6-benzylguanine and carmustine in treating patients who have recurrent metastatic or locally advanced soft tissue sarcoma
Detailed Description:
OBJECTIVES I Determine the objective response rate of patients with recurrent metastatic or locally advanced soft tissue sarcoma treated with O6-benzylguanine and carmustine II Determine the toxicity of this regimen in this patient population III Determine the duration of response time to progression and survival of these patients treated with this regimen
OUTLINE Patients receive O6-benzylguanine IV over 1 hour followed 1 hour later by carmustine IV over 15 minutes Treatment continues every 6 weeks for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression Patients with progressive disease are followed every 6 months until death Patients without progressive disease are followed every 3 months for 1 year
PROJECTED ACCRUAL A total of 12-35 patients will be accrued for this study within 14 months
OUTLINE Patients receive O6-benzylguanine IV over 1 hour followed 1 hour later by carmustine IV over 15 minutes Treatment continues every 6 weeks for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression Patients with progressive disease are followed every 6 months until death Patients without progressive disease are followed every 3 months for 1 year
PROJECTED ACCRUAL A total of 12-35 patients will be accrued for this study within 14 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 |
|---|---|---|---|
| UCCRC-10227 | None | None | None |
| UCCRC-T99-0088 | None | None | None |
| NCI-T99-0088 | None | None | None |