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.
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.
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
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There are 113 Locations for this study
Anchorage Alaska, 99508, United States
Little Rock Arkansas, 72205, United States
Castro Valley California, 94546, United States
Fairfield California, 94533, United States
Hayward California, 94545, United States
Los Angeles California, 90089, United States
Oakland California, 94602, United States
Oakland California, 94609, United States
Oakland California, 94609, United States
Pleasanton California, 94588, United States
San Pablo California, 94806, United States
Pensacola Florida, 32514, United States
Gainesville Georgia, 30501, United States
Savannah Georgia, 31403, United States
Boise Idaho, 83712, United States
Decatur Illinois, 62526, United States
Hines Illinois, 60141, United States
Maywood Illinois, 60153, United States
Springfield Illinois, 62781, United States
Davenport Iowa, 52803, United States
Salina Kansas, 67401, United States
Topeka Kansas, 66604, United States
Topeka Kansas, 66606, United States
Wichita Kansas, 67214, United States
Shreveport Louisiana, 71101, United States
Battle Creek Michigan, 49017, United States
Big Rapids Michigan, 49307, United States
Detroit Michigan, 48202, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49506, United States
Holland Michigan, 49423, United States
Mount Clemens Michigan, 48043, United States
Muskegon Michigan, 49442, United States
Port Huron Michigan, 48060, United States
Traverse City Michigan, 49684, United States
Joplin Missouri, 64804, United States
Kansas City Missouri, 64131, United States
Springfield Missouri, 65802, United States
Springfield Missouri, 65804, United States
Springfield Missouri, 65807, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59107, United States
Billings Montana, 59107, United States
Bozeman Montana, 59715, United States
Butte Montana, 59701, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Helena Montana, 59601, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Missoula Montana, 59801, United States
Missoula Montana, 59804, United States
Missoula Montana, 59807, United States
Missoula Montana, 59807, United States
Kearney Nebraska, 68848, United States
Middletown New York, 10940, United States
Rochester New York, 14620, United States
Rochester New York, 14623, United States
Rochester New York, 14642, United States
Gastonia North Carolina, 28053, United States
Goldsboro North Carolina, 27534, United States
Goldsboro North Carolina, 27534, United States
Rutherfordton North Carolina, 28139, United States
Wilson North Carolina, 27893, United States
Chillicothe Ohio, 45601, United States
Cincinnati Ohio, 45267, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43214, United States
Columbus Ohio, 43215, United States
Columbus Ohio, 43215, United States
Columbus Ohio, 43222, United States
Columbus Ohio, 43228, United States
Delaware Ohio, 43015, United States
Independence Ohio, 44131, United States
Lancaster Ohio, 43130, United States
Marietta Ohio, 45750, United States
Newark Ohio, 43055, United States
Springfield Ohio, 45504, United States
Springfield Ohio, 45505, United States
Westerville Ohio, 43081, United States
Wooster Ohio, 44691, United States
Youngstown Ohio, 44501, United States
Zanesville Ohio, 43701, United States
Gresham Oregon, 97030, United States
Milwaukie Oregon, 97222, United States
Portland Oregon, 97210, United States
Portland Oregon, 97213, United States
Portland Oregon, 97225, United States
Portland Oregon, 97225, United States
Portland Oregon, 97227, United States
Tualatin Oregon, 97062, United States
Anderson South Carolina, 29621, United States
Charleston South Carolina, 29401, United States
Spartanburg South Carolina, 29303, United States
Spartanburg South Carolina, 29303, United States
Knoxville Tennessee, 37920, United States
Dallas Texas, 75230, United States
Fort Sam Houston Texas, 78234, United States
Lackland AFB Texas, 78236, United States
Temple Texas, 76508, United States
American Fork Utah, 84003, United States
Logan Utah, 84321, United States
Murray Utah, 84107, United States
Ogden Utah, 84403, United States
Provo Utah, 84604, United States
Saint George Utah, 84770, United States
Salt Lake City Utah, 84103, United States
Salt Lake City Utah, 84106, United States
Danville Virginia, 24541, United States
Bellingham Washington, 98225, United States
Bremerton Washington, 98310, United States
Mt. Vernon Washington, 98273, United States
Seattle Washington, 98104, United States
Seattle Washington, 98104, United States
Seattle Washington, 98104, United States
Seattle Washington, 98112, United States
Seattle Washington, 98122, United States
Seattle Washington, 98122, United States
Seattle Washington, 98195, United States
Sedro-Wooley Washington, 98284, United States
Spokane Washington, 99202, United States
Vancouver Washington, 98668, United States
Wenatchee Washington, 98801, United States
Parkersburg West Virginia, 26102, United States
Sheridan Wyoming, 82801, United States
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