Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma
NCT ID: NCT00006385
Last Updated: 2011-11-08
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
INTERVENTIONAL
2000-09-30
Brief Summary
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PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy with or without biological therapy in treating patients who have metastatic melanoma.
Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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MART-1 antigen
gp100 antigen
incomplete Freund's adjuvant
recombinant interferon alfa
sargramostim
tyrosinase peptide
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Eastern Cooperative Oncology Group
NETWORK
Principal Investigators
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John M. Kirkwood, MD
Role: STUDY_CHAIR
University of Pittsburgh
Locations
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CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States
Emory University Hospital - Atlanta
Atlanta, Georgia, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States
CCOP - Evanston
Evanston, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
CCOP - Wichita
Wichita, Kansas, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Tuft-New England Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
CCOP - Northern New Jersey
Hackensack, New Jersey, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Albert Einstein Clinical Cancer Center
The Bronx, New York, United States
Ireland Cancer Center
Cleveland, Ohio, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, United States
Countries
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References
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Schaefer C, Butterfield LH, Lee S, Kim GG, Visus C, Albers A, Kirkwood JM, Whiteside TL. Function but not phenotype of melanoma peptide-specific CD8(+) T cells correlate with survival in a multiepitope peptide vaccine trial (ECOG 1696). Int J Cancer. 2012 Aug 15;131(4):874-84. doi: 10.1002/ijc.26481. Epub 2012 Jan 11.
Kirkwood JM, Lee S, Moschos SJ, Albertini MR, Michalak JC, Sander C, Whiteside T, Butterfield LH, Weiner L. Immunogenicity and antitumor effects of vaccination with peptide vaccine+/-granulocyte-monocyte colony-stimulating factor and/or IFN-alpha2b in advanced metastatic melanoma: Eastern Cooperative Oncology Group Phase II Trial E1696. Clin Cancer Res. 2009 Feb 15;15(4):1443-51. doi: 10.1158/1078-0432.CCR-08-1231.
Kirkwood JM, Lee S, Land S, et al.: E1696: final analysis of the clinical and immunological results of a multicenter ECOG phase II trial of multi-epitope peptide vaccination for stage IV melanoma with MART-1 (27-35), gp100 (209-217, 210M), and tyrosinase (368-376, 370D) (MGT) +/- IFNα2b and GM-CSF. [Abstract] J Clin Oncol 22 (Suppl 14): A-7502, 710s, 2004.
Kirkwood JM, Lee S, Land S, et al.: E1696: phase II trial of multi-epitope peptide vaccination for melanoma with MGT (MART-1 (27-35), gp100 (209-217, 210M) and tyrosinase (368-376, 370D))+/- IFN alfa-2b and GM-CSF--immunological and clinical results. [Abstract] 22: A-2850, 709, 2003.
Other Identifiers
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E-1696
Identifier Type: -
Identifier Source: secondary_id
CDR0000068263
Identifier Type: -
Identifier Source: org_study_id