Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072163
Status:
COMPLETED
Last Update Posted:
2013-01-17
First Post:
2003-11-04
Brief Title:
Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study Of Temozolomide And Thalidomide In Patients With Metastatic Melanoma In The Brain
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:
This phase II trial is studying how well giving temozolomide together with thalidomide works in treating patients with brain metastases secondary to melanoma Drugs used in chemotherapy such as temozolomide work in 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 with thalidomide may kill more tumor cells
Detailed Description:
OBJECTIVES Primary I Determine the objective response rate in patients with brain metastases secondary to melanoma treated with temozolomide and thalidomide
Secondary I Determine the toxic effects of and tolerance to this regimen in these patients
II Determine the objective response rate in extracranial metastases of patients treated with this regimen
III Determine the time to first disease progression intra- or extracranial in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive oral temozolomide once daily on days 1-42 and oral thalidomide once daily on days 1-56 Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity Patients achieving complete response CR receive 2 additional courses of therapy beyond CR
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually for up to 2 years
PROJECTED ACCRUAL A total of 21-50 patients will be accrued for this study within 15 years
Secondary I Determine the toxic effects of and tolerance to this regimen in these patients
II Determine the objective response rate in extracranial metastases of patients treated with this regimen
III Determine the time to first disease progression intra- or extracranial in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive oral temozolomide once daily on days 1-42 and oral thalidomide once daily on days 1-56 Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity Patients achieving complete response CR receive 2 additional courses of therapy beyond CR
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually for up to 2 years
PROJECTED ACCRUAL A total of 21-50 patients will be accrued for this study within 15 years
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 |
|---|---|---|---|
| CALGB-500102 | None | None | None |
| U10CA031946 | NIH | None | None |
| CDR0000335518 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |