Melanoma (Skin) Clinical Trial
Official title:
A Phase II Study of Temozolomide, Thalidomide, and Lomustine in the Treatment of Advanced Melanoma
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.
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.
;
Masking: Open Label, Primary Purpose: Treatment
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