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Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide and lomustine, use 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 and thalidomide with lomustine may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining temozolomide and thalidomide with lomustine in treating patients who have unresectable stage III or stage IV melanoma.


Clinical Trial Description

OBJECTIVES:

Primary

- Determine the antitumor activity of temozolomide, thalidomide, and lomustine, in terms of objective response rate, in patients with unresectable stage III or stage IV melanoma.

Secondary

- Determine the toxicity profile of this regimen in these patients.

- Determine the duration of response and overall survival of patients treated with this regimen.

OUTLINE: Patients receive oral temozolomide on days 1-42, oral thalidomide on days 1-56, and oral lomustine on days 1 and 29. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 2 years. ;


Study Design

Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00072345
Study type Interventional
Source Memorial Sloan Kettering Cancer Center
Contact
Status Completed
Phase Phase 2
Start date July 2003

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