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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00006385
Other study ID # CDR0000068263
Secondary ID E-1696
Status Completed
Phase Phase 2
First received October 4, 2000
Last updated November 5, 2011
Start date September 2000

Study information

Verified date December 2002
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date October 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
MART-1 antigen

gp100 antigen

incomplete Freund's adjuvant

recombinant interferon alfa

sargramostim

tyrosinase peptide


Locations

Country Name City State
United States Emory University Hospital - Atlanta Atlanta Georgia
United States Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Tuft-New England Medical Center Boston Massachusetts
United States Albert Einstein Clinical Cancer Center Bronx New York
United States Cancer Center at the University of Virginia Charlottesville Virginia
United States Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago Illinois
United States Veterans Affairs Medical Center - Lakeside Chicago Chicago Illinois
United States Ireland Cancer Center Cleveland Ohio
United States CCOP - Geisinger Clinic and Medical Center Danville Pennsylvania
United States Veterans Affairs Medical Center - Atlanta (Decatur) Decatur Georgia
United States CCOP - Iowa Oncology Research Association Des Moines Iowa
United States CCOP - Evanston Evanston Illinois
United States CCOP - St. Vincent Hospital Cancer Center, Green Bay Green Bay Wisconsin
United States CCOP - Northern New Jersey Hackensack New Jersey
United States Indiana University Cancer Center Indianapolis Indiana
United States Veterans Affairs Medical Center - Indianapolis (Roudebush) Indianapolis Indiana
United States CCOP - Kalamazoo Kalamazoo Michigan
United States University of Wisconsin Comprehensive Cancer Center Madison Wisconsin
United States Veterans Affairs Medical Center - Madison Madison Wisconsin
United States CCOP - Marshfield Medical Research and Education Foundation Marshfield Wisconsin
United States Cancer Institute of New Jersey New Brunswick New Jersey
United States CCOP - Ochsner New Orleans Louisiana
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States University of Pennsylvania Cancer Center Philadelphia Pennsylvania
United States University of Pittsburgh Cancer Institute Pittsburgh Pennsylvania
United States CCOP - Scottsdale Oncology Program Scottsdale Arizona
United States CCOP - Sioux Community Cancer Consortium Sioux Falls South Dakota
United States CCOP - Scott and White Hospital Temple Texas
United States CCOP - Toledo Community Hospital Toledo Ohio
United States CCOP - Carle Cancer Center Urbana Illinois
United States CCOP - Wichita Wichita Kansas

Sponsors (2)

Lead Sponsor Collaborator
Eastern Cooperative Oncology Group National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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

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. [Abs

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 adv — View Citation

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 — View Citation

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