RATIONALE: Drugs used in chemotherapy, such as temozolomide, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining temozolomide with radiation therapy may make the tumor cells more sensitive to radiation therapy and kill more tumor cells. PURPOSE: This phase II trial is studying how well giving temozolomide together with radiation therapy works in treating patients with stage IV malignant melanoma with measurable and unresectable cancer limited to the central nervous system.
OBJECTIVES: Primary * Determine the response rate in patients with stage IV malignant melanoma with measurable and unresectable disease of the central nervous system treated with temozolomide and radiotherapy. Secondary * Determine the safety of this regimen in these patients. * Determine the survival of patients treated with this regimen. * Determine the effect of this regimen on performance status and mental status of these patients. * Determine the response of extra-cranial disease in patients treated with this regimen. OUTLINE: Patients receive concurrent chemoradiotherapy comprising whole brain radiotherapy daily on days 1-5, 8-13, and 16-21 and oral temozolomide daily on days 1-5. Subsequent treatment with temozolomide repeats every 4 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 18-41 patients will be accrued for this study within 13-30 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States
McFarland Clinic, PC
Ames, Iowa, United States
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States
Confirmed response rate
Time frame: Up to 5 years
Progression-free survival
Time frame: Up to 5 years
Overall survival
Time frame: Up to 5 years
Change in performance status
Time frame: Up to 5 years
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