Temozolomide and Radiation Therapy in Treating Patients With Stage IV Malignant Melanoma With Measurable and Unresectable Cancer of the Central Nervous System
Melanoma (Skin), Metastatic Cancer
About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage IV melanoma, recurrent melanoma, tumors metastatic to brain
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage IV malignant melanoma with measurable and unresectable disease limited to the central nervous system (CNS) Study entry within 14 days of diagnosis of brain metastases Recursive partitioning analysis class I or II Disease for which no known standard therapy exists that is potentially curative or proven capable of extending life expectancy No meningeal carcinomatosis based on imaging studies or on positive results from CSF analysis No evidence of metastatic disease outside of the CNS PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 70-100% Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9.0 g/dL Hepatic AST no greater than 3 times upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN Renal Creatinine no greater than 1.5 times ULN Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No concurrent uncontrolled infection No other malignancy within the past 5 years except basal cell or squamous cell skin cancer treated with local resection only No prior allergy or intolerance to dacarbazine No hypersensitivity to temozolomide or any of its components PRIOR CONCURRENT THERAPY: Biologic therapy More than 4 weeks since prior biologic therapy More than 4 weeks since prior immunotherapy Chemotherapy No prior temozolomide More than 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered Endocrine therapy Concurrent steroids allowed if dose stable for at least 7 days prior to CNS imaging Radiotherapy More than 4 weeks since prior radiotherapy No prior radiotherapy to more than 15% of the bone marrow No prior radiotherapy to the head and neck area No prior radiosurgery
Sites / Locations
- Mayo Clinic Scottsdale
- Mayo Clinic - Jacksonville
- St. Francis Hospital and Health Centers - Beech Grove Campus
- McFarland Clinic, PC
- Cedar Rapids Oncology Associates
- Mercy Capitol Hospital
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center at Iowa Lutheran Hospital
- Siouxland Hematology-Oncology Associates, LLP
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Medical Oncology and Hematology Associates - West Des Moines
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Hutchinson Area Health Care
- Meeker County Memorial Hospital
- HealthEast Cancer Care at St. John's Hospital
- Minnesota Oncology Hematology, PA at Maplewood Cancer Center
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
- Hennepin County Medical Center - Minneapolis
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
- Mayo Clinic Cancer Center
- CCOP - Metro-Minnesota
- Saint Francis Cancer Center
- St. Joseph's Hospital
- Park Nicollet Health Services
- Regions Hospital Cancer Care Center
- United Hospital
- Ridgeview Medical Center
- Minnesota Oncology Hematology, PA - Woodbury
- Woodwinds Health Campus
- Grandview Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- CCOP - Dayton
- Middletown Regional Hospital
- Rapid City Regional Hospital
- Avera Cancer Institute
- Medical X-Ray Center, PC
- Sioux Valley Hospital and University of South Dakota Medical Center
Arms of the Study
Arm 1
Experimental
radiation + temozolomide
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.