Melanoma Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

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

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

64

Study ID:

NCT00104988

Recruitment Status:

Completed

Sponsor:

Southwest Oncology Group

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There are 113 Locations for this study

See Locations Near You

Alaska Regional Hospital Cancer Center
Anchorage Alaska, 99508, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Eden Medical Center
Castro Valley California, 94546, United States
North Bay Cancer Center
Fairfield California, 94533, United States
Saint Rose Hospital
Hayward California, 94545, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles California, 90089, United States
Highland General Hospital at St. George's University School of Medicine
Oakland California, 94602, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland California, 94609, United States
CCOP - Bay Area Tumor Institute
Oakland California, 94609, United States
Valley Care Medical Center
Pleasanton California, 94588, United States
Doctors Medical Center - San Pablo Campus
San Pablo California, 94806, United States
West Florida Cancer Institute at West Florida Hospital - Pensacola
Pensacola Florida, 32514, United States
Northeast Georgia Medical Center
Gainesville Georgia, 30501, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah Georgia, 31403, United States
St. Luke's Mountain States Tumor Institute - Boise
Boise Idaho, 83712, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur Illinois, 62526, United States
Veterans Affairs Medical Center - Hines
Hines Illinois, 60141, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood Illinois, 60153, United States
Regional Cancer Center at Memorial Medical Center
Springfield Illinois, 62781, United States
Genesis Regional Cancer Center at Genesis Medical Center
Davenport Iowa, 52803, United States
Tammy Walker Cancer Center at Salina Regional Health Center
Salina Kansas, 67401, United States
Stormont-Vail Cancer Center
Topeka Kansas, 66604, United States
St. Francis Comprehensive Cancer Center
Topeka Kansas, 66606, United States
Wesley Medical Center
Wichita Kansas, 67214, United States
Christus Schumpert Cancer Treatment Center
Shreveport Louisiana, 71101, United States
Battle Creek Health System Cancer Care Center
Battle Creek Michigan, 49017, United States
Mecosta County Medical Center
Big Rapids Michigan, 49307, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit Michigan, 48202, United States
CCOP - Grand Rapids
Grand Rapids Michigan, 49503, United States
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids Michigan, 49503, United States
Spectrum Health Hospital - Butterworth Campus
Grand Rapids Michigan, 49503, United States
Metro Health Hospital
Grand Rapids Michigan, 49506, United States
Holland Community Hospital
Holland Michigan, 49423, United States
Ted B. Wahby Cancer Center at Mount Clemens General Hospital
Mount Clemens Michigan, 48043, United States
Hackley Hospital
Muskegon Michigan, 49442, United States
Mercy Regional Cancer Center at Mercy Hospital
Port Huron Michigan, 48060, United States
Munson Medical Center
Traverse City Michigan, 49684, United States
Freeman Cancer Institute at Freeman Health System
Joplin Missouri, 64804, United States
CCOP - Kansas City
Kansas City Missouri, 64131, United States
CCOP - Cancer Research for the Ozarks
Springfield Missouri, 65802, United States
St. John's Regional Health Center
Springfield Missouri, 65804, United States
Hulston Cancer Center at Cox Medical Center South
Springfield Missouri, 65807, United States
CCOP - Montana Cancer Consortium
Billings Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings Montana, 59101, United States
St. Vincent Healthcare
Billings Montana, 59101, United States
Billings Clinic Cancer Center
Billings Montana, 59107, United States
Deaconess Billings Clinic - Downtown
Billings Montana, 59107, United States
Bozeman Deaconess Hospital
Bozeman Montana, 59715, United States
St. James Community Hospital
Butte Montana, 59701, United States
Big Sky Oncology
Great Falls Montana, 59405, United States
Sletten Regional Cancer Institute at Benefis Healthcare
Great Falls Montana, 59405, United States

Great Falls Montana, 59405, United States
St. Peter's Hospital
Helena Montana, 59601, United States
Glacier Oncology, PLLC
Kalispell Montana, 59901, United States
Kalispell Medical Oncology
Kalispell Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell Montana, 59901, United States
Community Medical Center
Missoula Montana, 59801, United States
Guardian Oncology and Center for Wellness
Missoula Montana, 59804, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula Montana, 59807, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula Montana, 59807, United States
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney Nebraska, 68848, United States
Tucker Center for Cancer Care at Orange Regional Medical Center
Middletown New York, 10940, United States
Highland Hospital of Rochester
Rochester New York, 14620, United States
Interlakes Oncology/Hematology PC
Rochester New York, 14623, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester New York, 14642, United States
CaroMont Cancer Center at Gaston Memorial Hospital
Gastonia North Carolina, 28053, United States
Wayne Memorial Hospital, Incorporated
Goldsboro North Carolina, 27534, United States
Wayne Radiation Oncology
Goldsboro North Carolina, 27534, United States
Rutherford Hospital
Rutherfordton North Carolina, 28139, United States
Wilson Medical Center
Wilson North Carolina, 27893, United States
Adena Regional Medical Center
Chillicothe Ohio, 45601, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati Ohio, 45267, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
Riverside Methodist Hospital Cancer Care
Columbus Ohio, 43214, United States
CCOP - Columbus
Columbus Ohio, 43215, United States
Grant Riverside Cancer Services
Columbus Ohio, 43215, United States
Mount Carmel Health - West Hospital
Columbus Ohio, 43222, United States
Doctors Hospital at Ohio Health
Columbus Ohio, 43228, United States
Grady Memorial Hospital
Delaware Ohio, 43015, United States
Community Oncology Group at Cleveland Clinic Cancer Center
Independence Ohio, 44131, United States
Fairfield Medical Center
Lancaster Ohio, 43130, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta Ohio, 45750, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark Ohio, 43055, United States
Mercy Medical Center
Springfield Ohio, 45504, United States
Community Hospital of Springfield and Clark County
Springfield Ohio, 45505, United States
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
Westerville Ohio, 43081, United States
Cleveland Clinic - Wooster
Wooster Ohio, 44691, United States
Tod Children's Hospital - Forum Health
Youngstown Ohio, 44501, United States
Genesis - Good Samaritan Hospital
Zanesville Ohio, 43701, United States
Legacy Mount Hood Medical Center
Gresham Oregon, 97030, United States
Providence Milwaukie Hospital
Milwaukie Oregon, 97222, United States
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
Portland Oregon, 97210, United States
Providence Cancer Center at Providence Portland Medical Center
Portland Oregon, 97213, United States
CCOP - Columbia River Oncology Program
Portland Oregon, 97225, United States
Providence St. Vincent Medical Center
Portland Oregon, 97225, United States
Legacy Emanuel Hospital and Health Center & Children's Hospital
Portland Oregon, 97227, United States
Legacy Meridian Park Hospital
Tualatin Oregon, 97062, United States
AnMed Health Cancer Center
Anderson South Carolina, 29621, United States
Roper St. Francis Cancer Center at Roper Hospital
Charleston South Carolina, 29401, United States
CCOP - Upstate Carolina
Spartanburg South Carolina, 29303, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg South Carolina, 29303, United States
U.T. Cancer Institute at University of Tennessee Medical Center
Knoxville Tennessee, 37920, United States
Medical City Dallas Hospital
Dallas Texas, 75230, United States
Brooke Army Medical Center
Fort Sam Houston Texas, 78234, United States
Wilford Hall Medical Center
Lackland AFB Texas, 78236, United States
CCOP - Scott and White Hospital
Temple Texas, 76508, United States
American Fork Hospital
American Fork Utah, 84003, United States
Logan Regional Hospital
Logan Utah, 84321, United States
Cottonwood Hospital Medical Center
Murray Utah, 84107, United States
McKay-Dee Hospital Center
Ogden Utah, 84403, United States
Utah Valley Regional Medical Center - Provo
Provo Utah, 84604, United States
Dixie Regional Medical Center - East Campus
Saint George Utah, 84770, United States
Latter Day Saints Hospital
Salt Lake City Utah, 84103, United States
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City Utah, 84106, United States
Danville Regional Medical Center
Danville Virginia, 24541, United States
St. Joseph Cancer Center
Bellingham Washington, 98225, United States
Olympic Hematology and Oncology
Bremerton Washington, 98310, United States
Skagit Valley Hospital Cancer Care Center
Mt. Vernon Washington, 98273, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98104, United States
Harborview Medical Center
Seattle Washington, 98104, United States
Minor and James Medical, PLLC
Seattle Washington, 98104, United States
Group Health Central Hospital
Seattle Washington, 98112, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle Washington, 98122, United States
Polyclinic First Hill
Seattle Washington, 98122, United States
University Cancer Center at University of Washington Medical Center
Seattle Washington, 98195, United States
North Puget Oncology at United General Hospital
Sedro-Wooley Washington, 98284, United States
Cancer Care Northwest - Spokane South
Spokane Washington, 99202, United States
Southwest Washington Medical Center Cancer Center
Vancouver Washington, 98668, United States
Wenatchee Valley Medical Center
Wenatchee Washington, 98801, United States
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
Parkersburg West Virginia, 26102, United States
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan Wyoming, 82801, United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

64

Study ID:

NCT00104988

Recruitment Status:

Completed

Sponsor:


Southwest Oncology Group

How clear is this clinincal trial information?

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