Melanoma (Skin) Clinical Trial
Official title:
A Phase II Trial of Combination Thalidomide Plus Temozolomide in Patients With Metastatic Malignant Melanoma
RATIONALE: Thalidomide may stop the growth of melanoma by blocking blood flow to the tumor.
It may also stimulate the immune system in different ways and stop tumor cells from growing.
Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth
of tumor cells, either by killing the cells or by stopping them from dividing. Giving
thalidomide together with temozolomide may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving thalidomide together with
temozolomide works in treating patients with stage IV melanoma that cannot be removed by
surgery.
OBJECTIVES:
- Determine the 6-month progression-free survival of patients with unresectable stage IV
malignant cutaneous melanoma treated with thalidomide and temozolomide.
- Determine the objective response (confirmed and unconfirmed complete response and
partial response) in patients with measurable disease treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
- Determine the qualitative and quantitative toxic effects of this regimen in these
patients.
OUTLINE: This is a multicenter study.
Patients receive oral thalidomide once daily on days 1-56 and temozolomide once daily on
days 1-42. Courses repeat every 56 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed at week 9, every 2 months until
disease progression, and then every 6 months until 3 years from study entry.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 14 months.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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