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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

John M. Kirkwood, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Federal Government

Study ID:

CDR0000068263

NCT ID:

NCT00006385

Start Date:

September 2000

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma

Name

Location

Emory University Hospital - AtlantaAtlanta, Georgia  30322
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Ireland Cancer CenterCleveland, Ohio  44106-5065
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
CCOP - WichitaWichita, Kansas  67214-3882
Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia  30033
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Veterans Affairs Medical Center - Indianapolis (Roudebush)Indianapolis, Indiana  46202
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Northern New JerseyHackensack, New Jersey  07601
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - OchsnerNew Orleans, Louisiana  70121
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
Veterans Affairs Medical Center - MadisonMadison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
CCOP - EvanstonEvanston, Illinois  60201
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
CCOP - Scott and White HospitalTemple, Texas  76508
Veterans Affairs Medical Center - Lakeside ChicagoChicago, Illinois  60611
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
CCOP - Marshfield Medical Research and Education FoundationMarshfield, Wisconsin  54449
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Tuft-New England Medical CenterBoston, Massachusetts  02111
Albert Einstein Clinical Cancer CenterBronx, New York  10461
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456