Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00104988
Status:
COMPLETED
Last Update Posted:
2012-08-22
First Post:
2005-03-03
Brief Title:
S0508 Thalidomide and Temozolomide in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase II Trial of Combination Thalidomide Plus Temozolomide in Patients With Metastatic Malignant Melanoma
Status:
COMPLETED
Status Verified Date:
2012-08
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 Thalidomide may stop the growth of melanoma by blocking blood flow to the tumor It may also stimulate the immune system in different ways and stop tumor cells from growing Drugs used in chemotherapy such as temozolomide work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving thalidomide together with temozolomide may kill more tumor cells
PURPOSE This phase II trial is studying how well giving thalidomide together with temozolomide works in treating patients with stage IV melanoma that cannot be removed by surgery
PURPOSE This phase II trial is studying how well giving thalidomide together with temozolomide works in treating patients with stage IV melanoma that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Determine the 6-month progression-free survival of patients with unresectable stage IV malignant cutaneous melanoma treated with thalidomide and temozolomide
Determine the objective response confirmed and unconfirmed complete response and partial response in patients with measurable disease treated with this regimen
Determine the overall survival of patients treated with this regimen
Determine the qualitative and quantitative toxic effects of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive oral thalidomide once daily on days 1-56 and temozolomide once daily on days 1-42 Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at week 9 every 2 months until disease progression and then every 6 months until 3 years from study entry
PROJECTED ACCRUAL A total of 55 patients will be accrued for this study within 14 months
Determine the 6-month progression-free survival of patients with unresectable stage IV malignant cutaneous melanoma treated with thalidomide and temozolomide
Determine the objective response confirmed and unconfirmed complete response and partial response in patients with measurable disease treated with this regimen
Determine the overall survival of patients treated with this regimen
Determine the qualitative and quantitative toxic effects of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive oral thalidomide once daily on days 1-56 and temozolomide once daily on days 1-42 Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at week 9 every 2 months until disease progression and then every 6 months until 3 years from study entry
PROJECTED ACCRUAL A total of 55 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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S0508 | OTHER | None | None |