Melanoma Clinical Trial

Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma

Summary

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.

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Full 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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Melanoma

Phase:

Phase 2

Study ID:

NCT00006385

Recruitment Status:

Completed

Sponsor:

Eastern Cooperative Oncology Group

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There are 30 Locations for this study

See Locations Near You

CCOP - Scottsdale Oncology Program
Scottsdale Arizona, 85259, United States
Emory University Hospital - Atlanta
Atlanta Georgia, 30322, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur Georgia, 30033, United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago Illinois, 60611, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago Illinois, 60611, United States
CCOP - Evanston
Evanston Illinois, 60201, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
Indiana University Cancer Center
Indianapolis Indiana, 46202, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis Indiana, 46202, United States
CCOP - Iowa Oncology Research Association
Des Moines Iowa, 50309, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
CCOP - Ochsner
New Orleans Louisiana, 70121, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland, 21231, United States
Tuft-New England Medical Center
Boston Massachusetts, 02111, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
CCOP - Kalamazoo
Kalamazoo Michigan, 49007, United States
CCOP - Northern New Jersey
Hackensack New Jersey, 07601, United States
Cancer Institute of New Jersey
New Brunswick New Jersey, 08903, United States
Albert Einstein Clinical Cancer Center
Bronx New York, 10461, United States
Ireland Cancer Center
Cleveland Ohio, 44106, United States
CCOP - Toledo Community Hospital
Toledo Ohio, 43623, United States
CCOP - Geisinger Clinic and Medical Center
Danville Pennsylvania, 17822, United States
University of Pennsylvania Cancer Center
Philadelphia Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
University of Pittsburgh Cancer Institute
Pittsburgh Pennsylvania, 15213, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls South Dakota, 57104, United States
CCOP - Scott and White Hospital
Temple Texas, 76508, United States
Cancer Center at the University of Virginia
Charlottesville Virginia, 22908, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay Wisconsin, 54301, United States
Veterans Affairs Medical Center - Madison
Madison Wisconsin, 53705, United States
University of Wisconsin Comprehensive Cancer Center
Madison Wisconsin, 53792, United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield Wisconsin, 54449, United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Study ID:

NCT00006385

Recruitment Status:

Completed

Sponsor:


Eastern Cooperative Oncology Group

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