Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072345
Status:
COMPLETED
Last Update Posted:
2013-01-18
First Post:
2003-11-04
Brief Title:
Temozolomide Thalidomide and Lomustine in Treating Patients With Unresectable Stage III or Stage IV Melanoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase II Study of Temozolomide Thalidomide and Lomustine in the Treatment of Advanced Melanoma
Status:
COMPLETED
Status Verified Date:
2013-01
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 such as temozolomide and lomustine use different ways to stop tumor cells from dividing so they stop growing or die Thalidomide may stop the growth of cancer by stopping blood flow to the tumor Combining temozolomide and thalidomide with lomustine may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining temozolomide and thalidomide with lomustine in treating patients who have unresectable stage III or stage IV melanoma
PURPOSE Phase II trial to study the effectiveness of combining temozolomide and thalidomide with lomustine in treating patients who have unresectable stage III or stage IV melanoma
Detailed Description:
OBJECTIVES
Primary
Determine the antitumor activity of temozolomide thalidomide and lomustine in terms of objective response rate in patients with unresectable stage III or stage IV melanoma
Secondary
Determine the toxicity profile of this regimen in these patients
Determine the duration of response and overall survival of patients treated with this regimen
OUTLINE Patients receive oral temozolomide on days 1-42 oral thalidomide on days 1-56 and oral lomustine on days 1 and 29 Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 12-35 patients will be accrued for this study within 2 years
Primary
Determine the antitumor activity of temozolomide thalidomide and lomustine in terms of objective response rate in patients with unresectable stage III or stage IV melanoma
Secondary
Determine the toxicity profile of this regimen in these patients
Determine the duration of response and overall survival of patients treated with this regimen
OUTLINE Patients receive oral temozolomide on days 1-42 oral thalidomide on days 1-56 and oral lomustine on days 1 and 29 Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 12-35 patients will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MSKCC-03084 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA008748 |
| P30CA008748 | NIH | None | None |