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Vaccination of Melanoma Patients With Tyrosinase YMD and gp100 IMD-Javelin Fusion Peptides/HSP70 Complexes: A Trial Comparing the Immunogenicity of Three Doses


Phase 1
18 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

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Trial Information

Vaccination of Melanoma Patients With Tyrosinase YMD and gp100 IMD-Javelin Fusion Peptides/HSP70 Complexes: A Trial Comparing the Immunogenicity of Three Doses


OBJECTIVES: I. Determine whether active specific immunization comprising tyrosinase and
gp100:209-217 (gp100) peptides fused with OVA BiP peptide and heat shock protein 70 (HSP70)
induces immunity against tyrosinase and gp100 in HLA-A2 positive patients with stage III or
IV melanoma. II. Determine the lowest optimally immunogenic dose of tyrosinase and gp100 in
these patients. III. Determine the tolerability of this regimen in these patients.

OUTLINE: This is a dose escalation study of tyrosinase and gp100:209-217 antigen (gp100).
Patients receive vaccination comprising tyrosinase and gp100 fused with OVA BiP peptide and
heat shock protein 70 (HSP70) subcutaneously on weeks 0, 1, 2, 6, and 18 for a total of 5
vaccinations in the absence of disease progression or unacceptable toxicity. Cohorts of 9
patients receive escalating doses of tyrosinase and gp100 until the lowest optimally
immunogenic dose is determined. The lowest optimally immunogenic dose is defined as the dose
at which 4 or more of 9 patients demonstrate T-cell responses.

PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven stage III or IV melanoma that is in
remission for 2-52 weeks after surgical resection OR minimally resectable HLA-A2 positive
Patients who are candidates for potentially curative surgery not eligible until after
surgery

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 80-100% Life
expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3 Platelet count greater
than 100,000/mm3 Hepatic: Bilirubin less than 2.5 mg/dL AST less than 74 Units/L LDH less
than 400 Units/L Alkaline phosphatase no greater than 1.5 times upper limit of normal
Renal: Not specified Pulmonary: No evidence of disease by chest x-ray or chest CT scan If
pulmonary function tests are abnormal, then abdominal CT scan must be performed Other: Not
pregnant Negative pregnancy test Fertile patients must use effective contraception No
other high risk malignancy within the past 2 years except basal cell or squamous cell skin
cancer or carcinoma in situ of the cervix No other medical condition that would preclude
compliance or immunologic response No new metastasis during study that requires
chemotherapy or radiotherapy

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent
chemotherapy Endocrine therapy: No corticosteroids during the interval between 1 week
prior to each immunization through 2 weeks after each immunization Radiotherapy: No
concurrent radiotherapy Surgery: Not specified Other: No antiinflammatory agents (e.g.,
aspirin) or other nonsteroidal antiinflammatory drugs during the interval between 1 week
prior to each immunization through 2 weeks after each immunization

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Philip O. Livingston, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

99-036

NCT ID:

NCT00005633

Start Date:

June 1999

Completion Date:

June 2002

Related Keywords:

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021