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A Randomized Phase II Trial of a Vaccine Combining Tyrosinase /gp100 Peptides Emulsified With Montanide ISA 51 Alone or With a Block Co-Polymer CRL 1005 or With GM-CSF for Patients With Resected Stages IIA and IIB Melanoma Grant Application Title: MART-1/gp100 Immune Responses to a Melanoma Vaccine


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

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Trial Information

A Randomized Phase II Trial of a Vaccine Combining Tyrosinase /gp100 Peptides Emulsified With Montanide ISA 51 Alone or With a Block Co-Polymer CRL 1005 or With GM-CSF for Patients With Resected Stages IIA and IIB Melanoma Grant Application Title: MART-1/gp100 Immune Responses to a Melanoma Vaccine


OBJECTIVES: I. Determine immune reactivity in HLA-A2 positive patients with resectable stage
IIA or IIB melanoma treated with vaccine comprising tyrosinase peptide and gp100 antigen
emulsified in Montanide ISA-51 (ISA-51) alone or in combination with sargramostim (GM-CSF).

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage
(IIA vs IIB). Patients are randomized to 1 of 2 treatment arms: Arm I: Patients receive
vaccine comprising tyrosinase peptide and gp100 antigen emulsified in Montanide ISA-51
(ISA-51) alone subcutaneously (SQ) once a week on weeks 0, 2, 4, 6, 10, 14, 18, and 26. Arm
II: Patients receive treatment as in arm I followed by sargramostim (GM-CSF) SQ for 5 days
after each vaccination. Patients are followed every 3 months for 2 years, every 6 months for
3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 50 patients (25 per arm) will be accrued for this study within
3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven stage IIA or stage IIB resectable cutaneous
melanoma rendered disease free Clinically uninvolved lymph nodes by physical examination
OR Pathologically uninvolved lymph nodes or sentinel lymph nodes after either complete
node dissection or selective lymphadenectomy, respectively No evidence of metastatic
disease within 28 days prior to definitive surgery HLA-A2 positive

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Hematopoietic: No
coagulation disorders No significant hematologic abnormality Hepatic: Bilirubin no greater
than 2.0 mg/dL No significant liver abnormality Renal: Creatinine no greater than 2.0
mg/dL No significant kidney abnormality Cardiovascular: No major medical illness of the
cardiovascular system Pulmonary: No major medical illness of the respiratory system Other:
No known allergic reaction to Montanide ISA-51 or sargramostim (GM-CSF) No major systemic
infections Not pregnant or nursing HIV negative Hepatitis B surface antigen negative
Hepatitis C antibody negative No prior uveitis or autoimmune inflammatory eye disease No
active autoimmune disease No other malignancy within past 5 years

PRIOR CONCURRENT THERAPY: At least 1 month since prior adjuvant therapy or any other
therapy for cancer Biologic therapy: Not specified Chemotherapy: Not specified Endocrine
therapy: No concurrent steroid therapy Radiotherapy: At least 1 month since prior
radiotherapy Surgery: See Disease Characteristics

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Jeffrey S. Weber, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066176 (10M-97-1)

NCT ID:

NCT00003274

Start Date:

March 1998

Completion Date:

November 2002

Related Keywords:

  • Melanoma (Skin)
  • stage II melanoma
  • Melanoma

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804