Melanoma (Skin) Clinical Trial
Official title:
Treatment of Patients With Metastatic Malignant Melanoma With Chemobiotherapy With Temozolomide, GM-CSF, IL2, and Interferon Alfa-2b Phase II Trial
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Biological therapies such as interleukin-2 and interferon alfa
stimulate a person's white blood cells to kill cancer cells or may interfere with the growth
of cancer cells. Combining chemotherapy with biological therapies may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of temozolomide followed by sargramostim,
interleukin-2, and interferon alfa in treating patients who have stage IV melanoma that
cannot be treated with surgery.
OBJECTIVES:
- Determine the response rate, time to progression, and survival of patients with
unresectable stage IV melanoma treated with temozolomide followed by sargramostim
(GM-CSF), interleukin-2, and interferon alfa.
- Determine the safety and tolerability of this regimen in this patient population.
- Determine the changes in quality of life over time in patients treated with this
regimen.
OUTLINE: This is a multicenter study.
Patients receive oral temozolomide on days 1-5, and sargramostim (GM-CSF), interleukin-2,
and interferon alfa subcutaneously on days 6-17. Treatment repeats every 28 days for 4-8
courses in the absence of disease progression or unacceptable toxicity. Patients with at
least stable or responsive disease after 8 courses of therapy may receive additional therapy
at investigators discretion.
Quality of life is assessed at baseline, every 8 weeks during study, and then at 1 month
after study.
Patients are followed at 1 month, every 3 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 2 years.
;
Primary Purpose: Treatment
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