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

NCT00005633 | Completed Phase 1

• 3 other identifiers: 99-036CDR0000067788NCI-G00-1771
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Melanoma (Skin)

Keywords

stage III melanoma; stage IV melanoma; recurrent melanoma

Interventions

OVA BiP peptide BIOLOGICAL

gp209-2M antigen BIOLOGICAL

recombinant 70-kD heat-shock protein BIOLOGICAL

tyrosinase peptide BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

HSP70 Heat-Shock Proteins

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Heat-Shock Proteins; Molecular Chaperones; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Philip O. Livingston, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 2, 2000
• First Posted: July 26, 2004
• Study Start: June 1, 1999
• Primary Completion: June 1, 2002
• Study Completion: June 1, 2002
• Last Updated: June 19, 2013

Record last verified: 2013-06

Locations

US (1)