A Phase II Trial of Combination Thalidomide Plus Temozolomide in Patients With Metastatic Malignant Melanoma
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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival at 6 months
6 months after registration
No
Joseph I. Clark, MD
Study Chair
Loyola University
United States: Federal Government
CDR0000412048
NCT00104988
June 2005
August 2009
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
Medical City Dallas Hospital | Dallas, Texas 75230 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
CCOP - Columbus | Columbus, Ohio 43206 |
CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
Wesley Medical Center | Wichita, Kansas 67214 |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
Wilford Hall Medical Center | Lackland Air Force Base, Texas 78236-5300 |
Latter Day Saints Hospital | Salt Lake City, Utah 84143 |
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
St. Luke's Mountain States Tumor Institute - Boise | Boise, Idaho 83712-6297 |
Tod Children's Hospital - Forum Health | Youngstown, Ohio 44501 |
Legacy Emanuel Hospital and Health Center & Children's Hospital | Portland, Oregon 97227 |
Interlakes Oncology/Hematology PC | Rochester, New York 14623 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Alaska Regional Hospital Cancer Center | Anchorage, Alaska 99508 |
Battle Creek Health System Cancer Care Center | Battle Creek, Michigan 49017 |
Holland Community Hospital | Holland, Michigan 49423 |
Hackley Hospital | Muskegon, Michigan 49443 |
Munson Medical Center | Traverse City, Michigan 49684 |
Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
St. Vincent Healthcare | Billings, Montana 59101 |
Deaconess Billings Clinic - Downtown | Billings, Montana 59101 |
Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
St. James Community Hospital | Butte, Montana 59701 |
Big Sky Oncology | Great Falls, Montana 59405 |
St. Peter's Hospital | Helena, Montana 59601 |
Kalispell Medical Oncology | Kalispell, Montana 59901 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Glacier Oncology, PLLC | Kalispell, Montana 59901 |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
Community Medical Center | Missoula, Montana 59801 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Doctors Hospital at Ohio Health | Columbus, Ohio 43228 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Grant Riverside Cancer Services | Columbus, Ohio 43215 |
Grady Memorial Hospital | Delaware, Ohio 43015 |
Fairfield Medical Center | Lancaster, Ohio 43130 |
Strecker Cancer Center at Marietta Memorial Hospital | Marietta, Ohio 45750 |
Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark, Ohio 43055 |
Community Hospital of Springfield and Clark County | Springfield, Ohio 45505 |
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital | Westerville, Ohio 43081 |
Genesis - Good Samaritan Hospital | Zanesville, Ohio 43701 |
American Fork Hospital | American Fork, Utah 84003 |
Logan Regional Hospital | Logan, Utah 84321 |
Cottonwood Hospital Medical Center | Murray, Utah 84107 |
McKay-Dee Hospital Center | Ogden, Utah 84403 |
Utah Cancer Specialists at UCS Cancer Center | Salt Lake City, Utah 84106 |
Olympic Hematology and Oncology | Bremerton, Washington 98310 |
Skagit Valley Hospital Cancer Care Center | Mt. Vernon, Washington 98273 |
University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
Harborview Medical Center | Seattle, Washington 98104 |
Group Health Central Hospital | Seattle, Washington 98104 |
North Puget Oncology at United General Hospital | Sedro-Wooley, Washington 98284 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Veterans Affairs Medical Center - Hines | Hines, Illinois 60141 |
Spectrum Health Hospital - Butterworth Campus | Grand Rapids, Michigan 49503 |
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
Mount Carmel Health - West Hospital | Columbus, Ohio 43222 |
Eden Medical Center | Castro Valley, California 94546 |
North Bay Cancer Center | Fairfield, California 94533 |
Saint Rose Hospital | Hayward, California 94545 |
Highland General Hospital at St. George's University School of Medicine | Oakland, California 94602 |
Alta Bates Summit Medical Center - Summit Campus | Oakland, California 94609 |
Valley Care Medical Center | Pleasanton, California 94588 |
Genesis Regional Cancer Center at Genesis Medical Center | Davenport, Iowa 52803 |
Stormont-Vail Cancer Center | Topeka, Kansas 66604 |
St. Francis Comprehensive Cancer Center | Topeka, Kansas 66606 |
Mecosta County Medical Center | Big Rapids, Michigan 49307 |
Highland Hospital of Rochester | Rochester, New York 14620 |
Wayne Radiation Oncology | Goldsboro, North Carolina 27534 |
Wilson Medical Center | Wilson, North Carolina 27893-3428 |
Community Oncology Group at Cleveland Clinic Cancer Center | Independence, Ohio 44131 |
Mercy Medical Center | Springfield, Ohio 45504 |
Cleveland Clinic - Wooster | Wooster, Ohio 44691 |
Legacy Mount Hood Medical Center | Gresham, Oregon 97030 |
Providence Milwaukie Hospital | Milwaukie, Oregon 97222 |
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center | Portland, Oregon 97210 |
Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
Providence St. Vincent Medical Center | Portland, Oregon 97225 |
Legacy Meridian Park Hospital | Tualatin, Oregon 97062 |
Dixie Regional Medical Center - East Campus | Saint George, Utah 84770 |
Danville Regional Medical Center | Danville, Virginia 24541 |
Minor and James Medical, PLLC | Seattle, Washington 98104 |
Polyclinic First Hill | Seattle, Washington 98122 |
Southwest Washington Medical Center Cancer Center | Vancouver, Washington 98668 |
Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
West Florida Cancer Institute at West Florida Hospital - Pensacola | Pensacola, Florida 32514 |
Tammy Walker Cancer Center at Salina Regional Health Center | Salina, Kansas 67401 |
Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
St. Joseph Cancer Center | Bellingham, Washington 98225 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital | Parkersburg, West Virginia 26102 |
Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
Good Samaritan Cancer Center at Good Samaritan Hospital | Kearney, Nebraska 68848-1990 |
Tucker Center for Cancer Care at Orange Regional Medical Center | Middletown, New York 10940-4199 |
Rutherford Hospital | Rutherfordton, North Carolina 28139 |
AnMed Health Cancer Center | Anderson, South Carolina 29621 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Freeman Cancer Institute at Freeman Health System | Joplin, Missouri 64803-2644 |
U.T. Cancer Institute at University of Tennessee Medical Center | Knoxville, Tennessee 37920-2911 |
Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Metro Health Hospital | Grand Rapids, Michigan 49506 |
Billings Clinic Cancer Center | Billings, Montana 59107-5100 |
Great Falls, Montana 59405 | |
Sletten Regional Cancer Institute at Benefis Healthcare | Great Falls, Montana 59405 |
Guardian Oncology and Center for Wellness | Missoula, Montana 59804 |
Roper St. Francis Cancer Center at Roper Hospital | Charleston, South Carolina 29401 |
Doctors Medical Center - San Pablo Campus | San Pablo, California 94806 |
Ted B. Wahby Cancer Center at Mount Clemens General Hospital | Mount Clemens, Michigan 48043 |
Christus Schumpert Cancer Treatment Center | Shreveport, Louisiana 71101 |
CaroMont Cancer Center at Gaston Memorial Hospital | Gastonia, North Carolina 28053 |