Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005961
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
2000-07-05
Brief Title:
O6-benzylguanine and Carmustine in Treating Patients With Unresectable Locally Recurrent or Metastatic Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of O6-Benzylguanine NSC 637037 and BCNU Carmustine in Patients With Metatstatic Melanoma
Status:
COMPLETED
Status Verified Date:
2003-04
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:
Phase II trial to study the effectiveness of O6-benzylguanine and carmustine in treating patients who have unresectable locally recurrent or metastatic melanoma Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than once chemotherapy drug may kill more tumor cells
Detailed Description:
OBJECTIVES
I Determine the objective clinical response rate and duration of response in patients with unresectable locally recurrent or metastatic melanoma treated with O6-benzylguanine and carmustine
II Compare the toxicities of this regimen in patients with no prior chemotherapy vs prior chemotherapy failure
III Correlate clinical response to this regimen in these patients with O6-alkylguanine DNA alkyltransferase AGT depletion and baseline AGT in peripheral blood mononuclear cells and tumor tissue
OUTLINE This is a multicenter study Patients are stratified according to prior chemotherapy chemotherapy failure vs chemotherapy naive
Patients receive O6-benzylguanine IV over 1 hour followed 1 hour later by carmustine IV over 1 hour on day 1 Treatment continues every 6 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity
Patients with disease progression are followed every 6 months All other patients are followed every 3 months for 1 year
I Determine the objective clinical response rate and duration of response in patients with unresectable locally recurrent or metastatic melanoma treated with O6-benzylguanine and carmustine
II Compare the toxicities of this regimen in patients with no prior chemotherapy vs prior chemotherapy failure
III Correlate clinical response to this regimen in these patients with O6-alkylguanine DNA alkyltransferase AGT depletion and baseline AGT in peripheral blood mononuclear cells and tumor tissue
OUTLINE This is a multicenter study Patients are stratified according to prior chemotherapy chemotherapy failure vs chemotherapy naive
Patients receive O6-benzylguanine IV over 1 hour followed 1 hour later by carmustine IV over 1 hour on day 1 Treatment continues every 6 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity
Patients with disease progression are followed every 6 months All other patients are followed every 3 months for 1 year
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 |
|---|---|---|---|
| CDR0000067943 | REGISTRY | PDQ Physician Data Query | None |
| UCCRC-10325 | None | None | None |
| CWRU-1699 | None | None | None |
| NCI-T99-0111 | None | None | None |