- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006385
Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma
Phase II Evaluation of Immunization With an HLA-A2 Multi-Epitope Peptide Vaccine Containing MART-1 (NSC #672643), gp100 (NSC #683472), and Tyrosinase (NSC #699048) Peptides Alone or in Combination With GM-CSF, IFN Alpha-2b, or GM-CSF + IFN Alpha-2b in Patients With Metastatic Melanoma
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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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Arizona
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Scottsdale, Arizona, United States, 85259-5404
- CCOP - Scottsdale Oncology Program
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University Hospital - Atlanta
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Decatur, Georgia, United States, 30033
- Veterans Affairs Medical Center - Atlanta (Decatur)
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Illinois
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Chicago, Illinois, United States, 60611
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
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Chicago, Illinois, United States, 60611-4494
- Veterans Affairs Medical Center - Lakeside Chicago
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Evanston, Illinois, United States, 60201
- CCOP - Evanston
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Urbana, Illinois, United States, 61801
- CCOP - Carle Cancer Center
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Indiana
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Indianapolis, Indiana, United States, 46202-5289
- Indiana University Cancer Center
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Indianapolis, Indiana, United States, 46202
- Veterans Affairs Medical Center - Indianapolis (Roudebush)
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Iowa
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Des Moines, Iowa, United States, 50309-1016
- CCOP - Iowa Oncology Research Association
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Kansas
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Wichita, Kansas, United States, 67214-3882
- CCOP - Wichita
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Louisiana
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New Orleans, Louisiana, United States, 70121
- CCOP - Ochsner
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Maryland
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Baltimore, Maryland, United States, 21231
- Sidney kimmel comprehensive cancer center at johns hopkins
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, United States, 02111
- Tuft-New England Medical Center
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Michigan
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Kalamazoo, Michigan, United States, 49007-3731
- CCOP - Kalamazoo
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New Jersey
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Hackensack, New Jersey, United States, 07601
- CCOP - Northern New Jersey
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New Brunswick, New Jersey, United States, 08903
- Cancer Institute of New Jersey
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New York
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Bronx, New York, United States, 10461
- Albert Einstein Clinical Cancer Center
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Ohio
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Cleveland, Ohio, United States, 44106-5065
- Ireland Cancer Center
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Toledo, Ohio, United States, 43623-3456
- CCOP - Toledo Community Hospital
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Pennsylvania
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Danville, Pennsylvania, United States, 17822-2001
- CCOP - Geisinger Clinic and Medical Center
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Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania Cancer Center
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Pittsburgh, Pennsylvania, United States, 15213-3489
- University of Pittsburgh Cancer Institute
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South Dakota
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Sioux Falls, South Dakota, United States, 57104
- CCOP - Sioux Community Cancer Consortium
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Texas
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Temple, Texas, United States, 76508
- CCOP - Scott and White Hospital
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Virginia
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Charlottesville, Virginia, United States, 22908
- Cancer Center at the University of Virginia
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Wisconsin
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Green Bay, Wisconsin, United States, 54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
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Madison, Wisconsin, United States, 53792-0001
- University of Wisconsin Comprehensive Cancer Center
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Madison, Wisconsin, United States, 53705-2286
- Veterans Affairs Medical Center - Madison
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Marshfield, Wisconsin, United States, 54449
- CCOP - Marshfield Medical Research and Education Foundation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Immunologic Factors
- Adjuvants, Immunologic
- Interferons
- Interferon-alpha
- Sargramostim
- Freund's Adjuvant
Other Study ID Numbers
- CDR0000068263
- E-1696
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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