S0508: Thalidomide and Temozolomide in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery
NCT ID: NCT00104988
Last Updated: 2012-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
64 participants
INTERVENTIONAL
2005-06-30
2009-08-31
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
temozolomide
75 mg/m\^2/day PO daily for 6 weeks followed by a 2-week break
thalidomide
200 mg/day PO daily
Interventions
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temozolomide
75 mg/m\^2/day PO daily for 6 weeks followed by a 2-week break
thalidomide
200 mg/day PO daily
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Joseph I. Clark, MD
Role: STUDY_CHAIR
Loyola University
Laura F. Hutchins, MD
Role: PRINCIPAL_INVESTIGATOR
University of Arkansas
Locations
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Alaska Regional Hospital Cancer Center
Anchorage, Alaska, 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
North Bay Cancer Center
Fairfield, California, United States
Saint Rose Hospital
Hayward, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Highland General Hospital at St. George's University School of Medicine
Oakland, California, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States
CCOP - Bay Area Tumor Institute
Oakland, California, United States
Valley Care Medical Center
Pleasanton, California, United States
Doctors Medical Center - San Pablo Campus
San Pablo, California, United States
West Florida Cancer Institute at West Florida Hospital - Pensacola
Pensacola, Florida, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States
St. Luke's Mountain States Tumor Institute - Boise
Boise, Idaho, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States
Veterans Affairs Medical Center - Hines
Hines, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, 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
Tammy Walker Cancer Center at Salina Regional Health Center
Salina, Kansas, United States
Stormont-Vail Cancer Center
Topeka, Kansas, United States
St. Francis Comprehensive Cancer Center
Topeka, Kansas, United States
Wesley Medical Center
Wichita, Kansas, United States
Christus Schumpert Cancer Treatment Center
Shreveport, Louisiana, United States
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States
Mecosta County Medical Center
Big Rapids, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States
CCOP - Grand Rapids
Grand 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
Metro Health Hospital
Grand Rapids, Michigan, United States
Holland Community Hospital
Holland, Michigan, United States
Ted B. Wahby Cancer Center at Mount Clemens General Hospital
Mount Clemens, Michigan, United States
Hackley Hospital
Muskegon, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
Freeman Cancer Institute at Freeman Health System
Joplin, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
St. John's Regional Health Center
Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, United States
St. Vincent Healthcare
Billings, Montana, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Deaconess Billings Clinic - Downtown
Billings, Montana, United States
Bozeman Deaconess Hospital
Bozeman, Montana, United States
St. James Community Hospital
Butte, Montana, United States
Big Sky Oncology
Great Falls, Montana, United States
Sletten Regional Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States
Great Falls, Montana, United States
St. Peter's Hospital
Helena, Montana, United States
Glacier Oncology, PLLC
Kalispell, Montana, United States
Kalispell Medical Oncology
Kalispell, Montana, United States
Kalispell Regional Medical Center
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
Tucker Center for Cancer Care at Orange Regional Medical Center
Middletown, New York, 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
CaroMont Cancer Center at Gaston Memorial Hospital
Gastonia, North Carolina, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, 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
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Grant Riverside Cancer Services
Columbus, Ohio, United States
Mount Carmel Health - West Hospital
Columbus, Ohio, United States
Doctors Hospital at Ohio Health
Columbus, Ohio, United States
Grady Memorial Hospital
Delaware, Ohio, United States
Community Oncology Group at Cleveland Clinic Cancer Center
Independence, Ohio, United States
Fairfield Medical Center
Lancaster, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States
Mercy Medical Center
Springfield, Ohio, United States
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
Westerville, Ohio, United States
Cleveland Clinic - Wooster
Wooster, Ohio, United States
Tod Children's Hospital - Forum Health
Youngstown, Ohio, United States
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States
Legacy Mount Hood Medical Center
Gresham, Oregon, United States
Providence Milwaukie Hospital
Milwaukie, Oregon, United States
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
Portland, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center & Children's Hospital
Portland, Oregon, United States
Legacy Meridian Park Hospital
Tualatin, Oregon, United States
AnMed Health Cancer Center
Anderson, South Carolina, United States
Roper St. Francis Cancer Center at Roper Hospital
Charleston, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
U.T. Cancer Institute at University of Tennessee Medical Center
Knoxville, Tennessee, United States
Medical City Dallas Hospital
Dallas, Texas, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
Wilford Hall Medical Center
Lackland Air Force Base, Texas, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
American Fork Hospital
American Fork, Utah, United States
Logan Regional Hospital
Logan, Utah, United States
Cottonwood Hospital Medical Center
Murray, Utah, United States
McKay-Dee Hospital Center
Ogden, Utah, United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, 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
Dixie Regional Medical Center - East Campus
St. George, Utah, United States
Danville Regional Medical Center
Danville, Virginia, United States
St. Joseph Cancer Center
Bellingham, Washington, United States
Olympic Hematology and Oncology
Bremerton, Washington, United States
Skagit Valley Hospital Cancer Care Center
Mount Vernon, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Harborview Medical Center
Seattle, Washington, United States
Minor and James Medical, PLLC
Seattle, Washington, United States
Group Health Central Hospital
Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States
Polyclinic First Hill
Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States
North Puget Oncology at United General Hospital
Sedro-Woolley, Washington, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, United States
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, United States
Wenatchee Valley Medical Center
Wenatchee, Washington, United States
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
Parkersburg, West Virginia, United States
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States
Countries
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References
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Clark JI, Moon J, Hutchins LF, Sosman JA, Kast WM, Da Silva DM, Liu PY, Thompson JA, Flaherty LE, Sondak VK. Phase 2 trial of combination thalidomide plus temozolomide in patients with metastatic malignant melanoma: Southwest Oncology Group S0508. Cancer. 2010 Jan 15;116(2):424-31. doi: 10.1002/cncr.24739.
Other Identifiers
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S0508
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000412048
Identifier Type: -
Identifier Source: org_study_id