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Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma Clinical research trials and Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma. Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma clinical trial. Participants oftentimes recieve the most expert healthcare available for their Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma  Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma
Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma
For Condition: Recurrent Melanoma,Stage 4 Melanoma
Status: No longer recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Biological therapies such as sargramostim and interferon alfa use different ways to stimulate the immune system and stop cancer cells from growing. It is not yet known if vaccine therapy if more effective with or without biological therapy for melanoma. PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy with or without biological therapy in treating patients who have metastatic melanoma.
Details: OBJECTIVES: - Determine immune response of vaccination with melanoma associated antigens (MART-1:27-35, gp100:209-217 (210M), and tyrosinase:368-376 (370D)) on the number of peptide specific CD8+ T-cell precursors in HLA-A2 positive patients with metastatic melanoma. - Determine the influence of sargramostim (GM-CSF) and/or interferon alfa-2b (IFN-A) on the immune responses of these patients and toxicity of this melanoma peptide vaccine. - Determine any antitumor and anti-pigmentary response that may result from immunization against MART-1, gp100 and tyrosinase peptides, and determine the relationship between such clinical observations and immune responses against lineage antigens with or without GM-CSF and/or IFN-A. - Compare the relapse free survival and overall survival of patients treated with melanoma peptide vaccine alone or in combination with GM-CSF and/or IFN-A. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 4 treatment arms. - Arm I: Patients receive multiepitope peptide (MEP) vaccine comprising MART-1:27-35, gp100:209-217 (210M), and tyrosinase:368-376 (370D) peptides. Each peptide is separately emulsified in Montanide ISA-51 and administered subcutaneously (SC) (for a total of 2 injections per peptide) on days 1 and 15. - Arm II: Patients receive MEP vaccine as in arm I and sargramostim (GM-CSF) subcutaneously (SC) daily on days 1-14. - Arm III: Patients receive MEP vaccine as in arm I and interferon alfa-2b SC three times a week. - Arm IV: Patients receive MEP vaccine as in arm I, GM-CSF as in arm II, and interferon alfa-2b as in arm III. Treatment continues every 4 weeks for a maximum of 13 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 92 patients (23 per arm) will be accrued for this study within 13-16 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven stage IV melanoma - Measurable disease - At least 1 lesion must be a minimum of 1.0 cm in diameter - Bone metastases are not considered to be measurable disease - No prior radiotherapy to area of measurable disease unless there is clearly progressive disease in this site or measurable disease exists outside the area of prior radiotherapy - HLA-A2 positive - No brain disease by MRI or CT scan within 4 weeks prior to randomization - Prior brain disease allowed if no evidence of active disease by 2 successive MRI evaluations completed at least 3 months apart PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - WBC at least 4,000/mm^3 - Platelet count at least 100,000/mm^3 - Lymphocyte count greater than 700/mm ^3 Hepatic: - SGOT no greater than 2 times upper limit of normal (ULN) - Bilirubin no greater than 2 times ULN - Alkaline phosphatase and lactic dehydrogenase no greater than 2 times ULN Renal: - Creatinine no greater than 1.8 mg/dL Other: - No significant detectable infection - HIV negative - No other malignancy within the past 5 years except: - Any carcinoma in situ - Lobular carcinoma in situ of the breast - Carcinoma in situ of the cervix - Atypical melanocytic hyperplasia - Melanoma in situ - Basal cell or squamous cell skin cancer - No autoimmune disorders or conditions of immunosuppression - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior MART-1:27-35, gp100:209-217 (210M), or tyrosinase:368-376 (370D) peptide - Greater than 4 weeks since prior adjuvant immunotherapy, including sargramostim (GM-CSF) or interferon alfa-2b Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy: - At least 2 weeks since prior and no concurrent systemic corticosteroids, including oral steroids (i.e., prednisone, dexamethasone); continuous use of topical steroid creams or ointments; or any inhalers containing steroids Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy for local control or palliation and recovered Surgery: - Recovered from any prior major surgery
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnKirkwood, Study Chair, University of Pittsburgh Cancer Institute
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, 46202
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Tuft-New England Medical Center
Boston, Massachusetts, 02111
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54301
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213-3489
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
CCOP - Ochsner
New Orleans, Louisiana, 70121
United States
CCOP - Evanston
Evanston, Illinois, 60201
United States
Albert Einstein Clinical Cancer Center
Bronx, New York, 10461
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611
United States
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, 53705-2286
United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, 54449
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, 60611-4494
United States
CCOP - Scott and White Hospital
Temple, Texas, 76508
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
CCOP - Toledo Community Hospital
Toledo, Ohio, 43623-3456
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-0001
United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, 30033
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
Additional Information:
Study ID Numbers: CDR0000068263; E-1696
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006385
Other Recurrent Melanoma Studies:
1. Vaccine Therapy in Treating Patients With Unresectable Metastatic Melanoma
2. Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma
3. Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma
4. Interferon alfa and Thalidomide in Treating Patients With Stage IV Melanoma
5. Monoclonal Antibody and Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Has Been Removed During Surgery
Related Studies:
Other Recurrent Melanoma Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma
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