Treatment of Patients With Metastatic Malignant Melanoma With Chemobiotherapy With Temozolomide, GM-CSF, IL2, and Interferon Alfa-2b Phase II Trial
- 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
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
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
Lynn E. Spitler, MD
Northern California Melanoma Center at St. Francis Memorial Hospital
United States: Federal Government
|University of Colorado Cancer Center at University of Colorado Health Sciences Center||Denver, Colorado 80010|
|John Wayne Cancer Institute at Saint John's Health Center||Santa Monica, California 90404|
|Saint Francis Memorial Hospital||San Francisco, California 94109|