Stage IV Melanoma Clinical Trial
Official title:
A Phase II Study Of Temozolomide And Thalidomide In Patients With Metastatic Melanoma In The Brain
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
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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