S0508: Thalidomide and Temozolomide in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery
Melanoma (Skin)

About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage IV melanoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed malignant cutaneous melanoma Unresectable, stage IV disease Unknown primary allowed Measurable or non-measurable disease If all known sites of disease are within a previously irradiated port, disease progression must be clearly demonstrated No brain metastases by CT scan or MRI within the past 42 days Prior brain metastasis allowed provided both of the following criteria are met: Completely resected and free of disease Treated with whole brain radiotherapy and completed treatment at least 28 days ago PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,000/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 9 g/dL (transfusions allowed) Hepatic Bilirubin ≤ 3 times upper limit of normal (ULN) SGOT or SGPT ≤ 2.5 times ULN (5 times ULN if liver metastases are present) Renal Creatinine ≤ 1.5 times ULN Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective double-method contraception for 4 weeks before, during, and for 4 weeks after study participation No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission No history of allergic reaction to dacarbazine PRIOR CONCURRENT THERAPY: Biologic therapy No prior thalidomide for stage IV disease At least 28 days since prior biological therapy At least 28 days since prior immunotherapy At least 28 days since prior adjuvant interferon alfa Chemotherapy No prior temozolomide or dacarbazine for stage IV disease At least 28 days since prior chemotherapy Endocrine therapy At least 28 days since prior hormonal therapy Radiotherapy See Disease Characteristics At least 28 days since prior radiotherapy Surgery See Disease Characteristics At least 28 days since prior surgery for primary and stage IV disease Other No more than 1 prior systemic therapy regimen for stage IV disease At least 28 days since other prior systemic therapy
Sites / Locations
- Alaska Regional Hospital Cancer Center
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Eden Medical Center
- North Bay Cancer Center
- Saint Rose Hospital
- USC/Norris Comprehensive Cancer Center and Hospital
- Highland General Hospital at St. George's University School of Medicine
- Alta Bates Summit Medical Center - Summit Campus
- CCOP - Bay Area Tumor Institute
- Valley Care Medical Center
- Doctors Medical Center - San Pablo Campus
- West Florida Cancer Institute at West Florida Hospital - Pensacola
- Northeast Georgia Medical Center
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- St. Luke's Mountain States Tumor Institute - Boise
- Decatur Memorial Hospital Cancer Care Institute
- Veterans Affairs Medical Center - Hines
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- Regional Cancer Center at Memorial Medical Center
- Genesis Regional Cancer Center at Genesis Medical Center
- Tammy Walker Cancer Center at Salina Regional Health Center
- Stormont-Vail Cancer Center
- St. Francis Comprehensive Cancer Center
- Wesley Medical Center
- Christus Schumpert Cancer Treatment Center
- Battle Creek Health System Cancer Care Center
- Mecosta County Medical Center
- Josephine Ford Cancer Center at Henry Ford Hospital
- CCOP - Grand Rapids
- Lacks Cancer Center at Saint Mary's Health Care
- Spectrum Health Hospital - Butterworth Campus
- Metro Health Hospital
- Holland Community Hospital
- Ted B. Wahby Cancer Center at Mount Clemens General Hospital
- Hackley Hospital
- Mercy Regional Cancer Center at Mercy Hospital
- Munson Medical Center
- Freeman Cancer Institute at Freeman Health System
- CCOP - Kansas City
- CCOP - Cancer Research for the Ozarks
- St. John's Regional Health Center
- Hulston Cancer Center at Cox Medical Center South
- CCOP - Montana Cancer Consortium
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare
- Billings Clinic Cancer Center
- Deaconess Billings Clinic - Downtown
- Bozeman Deaconess Hospital
- St. James Community Hospital
- Big Sky Oncology
- Sletten Regional Cancer Institute at Benefis Healthcare
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology
- Kalispell Regional Medical Center
- Community Medical Center
- Guardian Oncology and Center for Wellness
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Good Samaritan Cancer Center at Good Samaritan Hospital
- Tucker Center for Cancer Care at Orange Regional Medical Center
- Highland Hospital of Rochester
- Interlakes Oncology/Hematology PC
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- CaroMont Cancer Center at Gaston Memorial Hospital
- Wayne Memorial Hospital, Incorporated
- Wayne Radiation Oncology
- Rutherford Hospital
- Wilson Medical Center
- Adena Regional Medical Center
- Charles M. Barrett Cancer Center at University Hospital
- Cleveland Clinic Taussig Cancer Center
- Riverside Methodist Hospital Cancer Care
- CCOP - Columbus
- Grant Riverside Cancer Services
- Mount Carmel Health - West Hospital
- Doctors Hospital at Ohio Health
- Grady Memorial Hospital
- Community Oncology Group at Cleveland Clinic Cancer Center
- Fairfield Medical Center
- Strecker Cancer Center at Marietta Memorial Hospital
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
- Mercy Medical Center
- Community Hospital of Springfield and Clark County
- Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
- Cleveland Clinic - Wooster
- Tod Children's Hospital - Forum Health
- Genesis - Good Samaritan Hospital
- Legacy Mount Hood Medical Center
- Providence Milwaukie Hospital
- Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
- Providence Cancer Center at Providence Portland Medical Center
- CCOP - Columbia River Oncology Program
- Providence St. Vincent Medical Center
- Legacy Emanuel Hospital and Health Center & Children's Hospital
- Legacy Meridian Park Hospital
- AnMed Health Cancer Center
- Roper St. Francis Cancer Center at Roper Hospital
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- U.T. Cancer Institute at University of Tennessee Medical Center
- Medical City Dallas Hospital
- Brooke Army Medical Center
- Wilford Hall Medical Center
- CCOP - Scott and White Hospital
- American Fork Hospital
- Logan Regional Hospital
- Cottonwood Hospital Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center - Provo
- Dixie Regional Medical Center - East Campus
- Latter Day Saints Hospital
- Utah Cancer Specialists at UCS Cancer Center
- Danville Regional Medical Center
- St. Joseph Cancer Center
- Olympic Hematology and Oncology
- Skagit Valley Hospital Cancer Care Center
- Fred Hutchinson Cancer Research Center
- Harborview Medical Center
- Minor and James Medical, PLLC
- Group Health Central Hospital
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- Polyclinic First Hill
- University Cancer Center at University of Washington Medical Center
- North Puget Oncology at United General Hospital
- Cancer Care Northwest - Spokane South
- Southwest Washington Medical Center Cancer Center
- Wenatchee Valley Medical Center
- Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
- Welch Cancer Center at Sheridan Memorial Hospital
Arms of the Study
Arm 1
Experimental
Thalidomide and Temozolomide
Patients receive oral thalidomide once daily on days 1-56 and temozolomide once daily on days 1-42. Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity.