NCT00072163

Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma

A Phase II Study Of Temozolomide And Thalidomide In Patients With Metastatic Melanoma In The Brain

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 1.5 years.

Conditions

• Recurrent Melanoma
• Stage IV Melanoma
• Tumors Metastatic to Brain

Interventions

Type	Name	Description
DRUG	temozolomide	Given orally
DRUG	thalidomide	Given orally

Timeline

• Start date: 2003-10-01
• Primary completion: 2006-09-01
• First posted: 2003-11-06
• Last updated: 2013-01-17

Locations

1 site across 1 country: United States