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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Mercy Capitol Hospital
Des Moines, Iowa, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, United States
Start Date
January 1, 2004
Primary Completion Date
March 1, 2005
Completion Date
March 1, 2010
Last Updated
December 15, 2016
41
ACTUAL participants
temozolomide
DRUG
radiation therapy
RADIATION
Lead Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
NCT04657068
NCT04585750
Data Source & Attribution
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