Metastatic Cancer Clinical Trial
Official title:
A Systemic Temozolomide Treatment Of Melanoma Present In The Central Nervous System
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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