S0508: Thalidomide and Temozolomide in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery
- Registration Number
- NCT00104988
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: Thalidomide may stop the growth of melanoma by blocking blood flow to the tumor. It may also stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving thalidomide together with temozolomide may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving thalidomide together with temozolomide works in treating patients with stage IV melanoma that cannot be removed by surgery.
- Detailed Description
OBJECTIVES:
* Determine the 6-month progression-free survival of patients with unresectable stage IV malignant cutaneous melanoma treated with thalidomide and temozolomide.
* Determine the objective response (confirmed and unconfirmed complete response and partial response) in patients with measurable disease treated with this regimen.
* Determine the overall survival of patients treated with this regimen.
* Determine the qualitative and quantitative toxic effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
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.
After completion of study treatment, patients are followed at week 9, every 2 months until disease progression, and then every 6 months until 3 years from study entry.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 14 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Thalidomide and Temozolomide 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. Thalidomide and Temozolomide thalidomide 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.
- Primary Outcome Measures
Name Time Method Progression-free survival at 6 months 6 months after registration Objective response (confirmed and unconfirmed complete and partial responses) Week 9, every 8 weeks thereafter until progression 6-month overall survival six months after registration
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (131)
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
U.T. Cancer Institute at University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States
Cottonwood Hospital Medical Center
🇺🇸Murray, Utah, United States
Alaska Regional Hospital Cancer Center
🇺🇸Anchorage, Alaska, United States
Battle Creek Health System Cancer Care Center
🇺🇸Battle Creek, Michigan, United States
Mecosta County Medical Center
🇺🇸Big Rapids, Michigan, United States
Lacks Cancer Center at Saint Mary's Health Care
🇺🇸Grand Rapids, Michigan, United States
Spectrum Health Hospital - Butterworth Campus
🇺🇸Grand Rapids, Michigan, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Ted B. Wahby Cancer Center at Mount Clemens General Hospital
🇺🇸Mount Clemens, Michigan, United States
Bozeman Deaconess Hospital
🇺🇸Bozeman, Montana, United States
Mercy Regional Cancer Center at Mercy Hospital
🇺🇸Port Huron, Michigan, United States
Northern Rockies Radiation Oncology Center
🇺🇸Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
St. Vincent Healthcare
🇺🇸Billings, Montana, United States
Billings Clinic Cancer Center
🇺🇸Billings, Montana, United States
Big Sky Oncology
🇺🇸Great Falls, Montana, United States
Sletten Regional Cancer Institute at Benefis Healthcare
🇺🇸Great Falls, Montana, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
Kalispell Medical Oncology
🇺🇸Kalispell, Montana, United States
Community Medical Center
🇺🇸Missoula, Montana, United States
Guardian Oncology and Center for Wellness
🇺🇸Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
Good Samaritan Cancer Center at Good Samaritan Hospital
🇺🇸Kearney, Nebraska, United States
Doctors Hospital at Ohio Health
🇺🇸Columbus, Ohio, United States
Holland Community Hospital
🇺🇸Holland, Michigan, United States
Mount Carmel Health - West Hospital
🇺🇸Columbus, Ohio, United States
Tod Children's Hospital - Forum Health
🇺🇸Youngstown, Ohio, United States
McKay-Dee Hospital Center
🇺🇸Ogden, Utah, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
St. James Community Hospital
🇺🇸Butte, Montana, United States
Grant Riverside Cancer Services
🇺🇸Columbus, Ohio, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
🇺🇸Seattle, Washington, United States
Minor and James Medical, PLLC
🇺🇸Seattle, Washington, United States
Polyclinic First Hill
🇺🇸Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Saint Rose Hospital
🇺🇸Hayward, California, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
CCOP - Grand Rapids
🇺🇸Grand Rapids, Michigan, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Eden Medical Center
🇺🇸Castro Valley, California, United States
Highland General Hospital at St. George's University School of Medicine
🇺🇸Oakland, California, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
North Bay Cancer Center
🇺🇸Fairfield, California, United States
St. John's Regional Health Center
🇺🇸Springfield, Missouri, United States
Metro Health Hospital
🇺🇸Grand Rapids, Michigan, United States
Legacy Mount Hood Medical Center
🇺🇸Gresham, Oregon, United States
Tucker Center for Cancer Care at Orange Regional Medical Center
🇺🇸Middletown, New York, United States
CaroMont Cancer Center at Gaston Memorial Hospital
🇺🇸Gastonia, North Carolina, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
Providence Milwaukie Hospital
🇺🇸Milwaukie, Oregon, United States
Legacy Meridian Park Hospital
🇺🇸Tualatin, Oregon, United States
American Fork Hospital
🇺🇸American Fork, Utah, United States
Logan Regional Hospital
🇺🇸Logan, Utah, United States
AnMed Health Cancer Center
🇺🇸Anderson, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Freeman Cancer Institute at Freeman Health System
🇺🇸Joplin, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
🇺🇸Springfield, Missouri, United States
Wayne Radiation Oncology
🇺🇸Goldsboro, North Carolina, United States
Rutherford Hospital
🇺🇸Rutherfordton, North Carolina, United States
Wilson Medical Center
🇺🇸Wilson, North Carolina, United States
Adena Regional Medical Center
🇺🇸Chillicothe, Ohio, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, United States
Riverside Methodist Hospital Cancer Care
🇺🇸Columbus, Ohio, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Grady Memorial Hospital
🇺🇸Delaware, Ohio, United States
Community Oncology Group at Cleveland Clinic Cancer Center
🇺🇸Independence, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
🇺🇸Newark, Ohio, United States
Fairfield Medical Center
🇺🇸Lancaster, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
🇺🇸Marietta, Ohio, United States
Mercy Medical Center
🇺🇸Springfield, Ohio, United States
Community Hospital of Springfield and Clark County
🇺🇸Springfield, Ohio, United States
Cleveland Clinic - Wooster
🇺🇸Wooster, Ohio, United States
Genesis - Good Samaritan Hospital
🇺🇸Zanesville, Ohio, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
Wilford Hall Medical Center
🇺🇸Lackland AFB, Texas, United States
Latter Day Saints Hospital
🇺🇸Salt Lake City, Utah, United States
Utah Cancer Specialists at UCS Cancer Center
🇺🇸Salt Lake City, Utah, United States
Tammy Walker Cancer Center at Salina Regional Health Center
🇺🇸Salina, Kansas, United States
Welch Cancer Center at Sheridan Memorial Hospital
🇺🇸Sheridan, Wyoming, United States
Josephine Ford Cancer Center at Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
🇺🇸Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center & Children's Hospital
🇺🇸Portland, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
Alta Bates Summit Medical Center - Summit Campus
🇺🇸Oakland, California, United States
Valley Care Medical Center
🇺🇸Pleasanton, California, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
Doctors Medical Center - San Pablo Campus
🇺🇸San Pablo, California, United States
St. Luke's Mountain States Tumor Institute - Boise
🇺🇸Boise, Idaho, United States
West Florida Cancer Institute at West Florida Hospital - Pensacola
🇺🇸Pensacola, Florida, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
Northeast Georgia Medical Center
🇺🇸Gainesville, Georgia, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Veterans Affairs Medical Center - Hines
🇺🇸Hines, Illinois, United States
Regional Cancer Center at Memorial Medical Center
🇺🇸Springfield, Illinois, United States
Genesis Regional Cancer Center at Genesis Medical Center
🇺🇸Davenport, Iowa, United States
Stormont-Vail Cancer Center
🇺🇸Topeka, Kansas, United States
St. Francis Comprehensive Cancer Center
🇺🇸Topeka, Kansas, United States
Christus Schumpert Cancer Treatment Center
🇺🇸Shreveport, Louisiana, United States
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
🇺🇸Westerville, Ohio, United States
Utah Valley Regional Medical Center - Provo
🇺🇸Provo, Utah, United States
Dixie Regional Medical Center - East Campus
🇺🇸Saint George, Utah, United States
St. Joseph Cancer Center
🇺🇸Bellingham, Washington, United States
Olympic Hematology and Oncology
🇺🇸Bremerton, Washington, United States
Danville Regional Medical Center
🇺🇸Danville, Virginia, United States
Skagit Valley Hospital Cancer Care Center
🇺🇸Mt. Vernon, Washington, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Group Health Central Hospital
🇺🇸Seattle, Washington, United States
Cancer Care Northwest - Spokane South
🇺🇸Spokane, Washington, United States
North Puget Oncology at United General Hospital
🇺🇸Sedro-Wooley, Washington, United States
Wenatchee Valley Medical Center
🇺🇸Wenatchee, Washington, United States
Southwest Washington Medical Center Cancer Center
🇺🇸Vancouver, Washington, United States
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
🇺🇸Parkersburg, West Virginia, United States
Decatur Memorial Hospital Cancer Care Institute
🇺🇸Decatur, Illinois, United States
Wesley Medical Center
🇺🇸Wichita, Kansas, United States
Highland Hospital of Rochester
🇺🇸Rochester, New York, United States
Interlakes Oncology/Hematology PC
🇺🇸Rochester, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Roper St. Francis Cancer Center at Roper Hospital
🇺🇸Charleston, South Carolina, United States
Deaconess Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
Hackley Hospital
🇺🇸Muskegon, Michigan, United States