A Phase II Study Of Temozolomide And Thalidomide In Patients With Metastatic Melanoma In The Brain
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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate (defined as complete or partial)
90% confidence intervals will be used.
Up to 5 years
No
Susan Krown
Principal Investigator
Cancer and Leukemia Group B
United States: Food and Drug Administration
NCI-2012-02560
NCT00072163
October 2003
Name | Location |
---|---|
Cancer and Leukemia Group B | Chicago, Illinois 60606 |