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Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center Identifier:
First received: May 2, 2000
Last updated: June 18, 2013
Last verified: June 2013

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with stage III or stage IV melanoma.

Condition Intervention Phase
Melanoma (Skin)
Biological: OVA BiP peptide
Biological: gp209-2M antigen
Biological: recombinant 70-kD heat-shock protein
Biological: tyrosinase peptide
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Vaccination of Melanoma Patients With Tyrosinase YMD and gp100 IMD-Javelin Fusion Peptides/HSP70 Complexes: A Trial Comparing the Immunogenicity of Three Doses

Resource links provided by NLM:

Further study details as provided by Memorial Sloan Kettering Cancer Center:

Study Start Date: June 1999
Study Completion Date: June 2002
Primary Completion Date: June 2002 (Final data collection date for primary outcome measure)
Detailed Description:

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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Please refer to this study by its identifier: NCT00005633

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Philip O. Livingston, MD Memorial Sloan Kettering Cancer Center
  More Information Identifier: NCT00005633     History of Changes
Other Study ID Numbers: 99-036
CDR0000067788 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: May 2, 2000
Last Updated: June 18, 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:
stage III melanoma
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas processed this record on April 28, 2017