Melanoma Clinical Trial
S9804: Vinorelbine in Treating Patients With Stage IV Melanoma
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating patients who have stage IV melanoma that has been previously treated.
Full Description
OBJECTIVES: I. Evaluate the response rate (complete or partial) of patients with disseminated stage IV melanoma treated with vinorelbine. II. Assess the qualitative and quantitative toxic effects of vinorelbine in these patients.
OUTLINE: Patients receive vinorelbine by IV over 6 to 10 minutes weekly. Treatment continues in the absence of disease progression, unacceptable toxicity, or complete response to therapy. Patients are followed every 3 months for 2 years and every 6 months thereafter.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed, pathologically verified, disseminated stage IV melanoma that is surgically incurable Any T, any N, M1a or M1b Must have received at least one prior chemotherapy, biologic/immunotherapy, or combination regimen for metastatic disease At least 4 weeks since prior systemic therapy Bidimensionally measurable disease by physical exam, CT scan, radionuclide scan, or plain x-ray outside previously irradiated area No brain metastases by MRI or CT scan (except completely resected brain tumors that have undergone whole brain radiotherapy)
PATIENT CHARACTERISTICS: Age: Not specified Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: HIV negative Not pregnant or nursing Fertile patients must use effective contraception No other prior malignancy within the past 5 years, except: Adequately treated basal cell or squamous cell skin cancer Adequately treated stage I or II cancer Carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 4 weeks since prior adjuvant biologic or immunotherapy Chemotherapy: See Disease Characteristics No prior adjuvant chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: At least 4 weeks since prior surgery
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There are 78 Locations for this study
Mobile Alabama, 36688, United States
Phoenix Arizona, 85006, United States
Phoenix Arizona, 85012, United States
Tucson Arizona, 85723, United States
Tucson Arizona, 85724, United States
Little Rock Arkansas, 72205, United States
Little Rock Arkansas, 72205, United States
Duarte California, 91010, United States
Long Beach California, 90822, United States
Los Angeles California, 90033, United States
Los Angeles California, 90095, United States
Martinez California, 94553, United States
Oakland California, 94609, United States
Orange California, 92868, United States
Sacramento California, 95817, United States
San Francisco California, 94115, United States
San Francisco California, 94121, United States
Santa Rosa California, 95403, United States
Travis Air Force Base California, 94535, United States
Denver Colorado, 80220, United States
Denver Colorado, 80262, United States
Atlanta Georgia, 30342, United States
Fort Gordon Georgia, 30905, United States
Honolulu Hawaii, 96813, United States
Hines Illinois, 60141, United States
Maywood Illinois, 60153, United States
Springfield Illinois, 62526, United States
Kansas City Kansas, 66160, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67218, United States
Lexington Kentucky, 40511, United States
Lexington Kentucky, 40536, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70112, United States
Shreveport Louisiana, 71130, United States
Shreveport Louisiana, 71130, United States
Boston Massachusetts, 02118, United States
Jamaica Plain Massachusetts, 02130, United States
Ann Arbor Michigan, 48105, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
Grand Rapids Michigan, 49503, United States
Southfield Michigan, 48075, United States
Biloxi Mississippi, 39531, United States
Jackson Mississippi, 39216, United States
Jackson Mississippi, 39216, United States
Keesler AFB Mississippi, 39534, United States
Kansas City Missouri, 64128, United States
Kansas City Missouri, 64131, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63141, United States
Springfield Missouri, 65807, United States
Billings Montana, 59101, United States
Albuquerque New Mexico, 87108, United States
Albuquerque New Mexico, 87131, United States
Brooklyn New York, 11209, United States
New York New York, 10032, United States
Cincinnati Ohio, 45219, United States
Cincinnati Ohio, 45220, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43206, United States
Dayton Ohio, 45428, United States
Kettering Ohio, 45429, United States
Oklahoma City Oklahoma, 73104, United States
Oklahoma City Oklahoma, 73104, United States
Portland Oregon, 97201, United States
Portland Oregon, 97207, United States
Portland Oregon, 97213, United States
Greenville South Carolina, 29615, United States
Spartanburg South Carolina, 29303, United States
Fort Sam Houston Texas, 78234, United States
Galveston Texas, 77555, United States
Lubbock Texas, 79423, United States
San Antonio Texas, 78284, United States
San Antonio Texas, 78284, United States
Temple Texas, 76504, United States
Temple Texas, 76508, United States
Salt Lake City Utah, 84132, United States
Salt Lake City Utah, 84148, United States
Seattle Washington, 98101, United States
Seattle Washington, 98104, United States
Seattle Washington, 98108, United States
Tacoma Washington, 98405, United States
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