Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma
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|ClinicalTrials.gov Identifier: NCT00072163|
Recruitment Status : Completed
First Posted : November 6, 2003
Last Update Posted : January 17, 2013
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Melanoma Stage IV Melanoma Tumors Metastatic to Brain||Drug: temozolomide Drug: thalidomide||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Of Temozolomide And Thalidomide In Patients With Metastatic Melanoma In The Brain|
|Study Start Date :||October 2003|
|Actual Primary Completion Date :||September 2006|
Experimental: Treatment (temozolomide, thalidomide)
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 CR receive 2 additional courses of therapy beyond CR.
- Response rate (defined as complete or partial) [ Time Frame: Up to 5 years ]90% confidence intervals will be used.
- Time to first progression [ Time Frame: Up to 5 years ]Kaplan-Meier method will be used.
- Overall survival [ Time Frame: Up to 5 years ]Kaplan-Meier method will be used.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00072163
|United States, Illinois|
|Cancer and Leukemia Group B|
|Chicago, Illinois, United States, 60606|
|Principal Investigator:||Susan Krown||Cancer and Leukemia Group B|