A Phase I Study of gp100 Human Melanoma Peptide Vaccine With Incomplete Freund's Adjuvant

NCT00001439 | Completed Phase 1

• 2 other identifiers: 95014595-C-0145
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I study of melanoma tumor antigen peptide vaccines. The nine amino acid peptides representing HLA-A2 restricted T cell epitope of the melanoma antigen, gp100 will be administered to patients emulsified in Incomplete Freund's Adjuvant, (IFA). The study is designed to evaluate the toxicity, immunologic effects and potential therapeutic role of repeated doses of gp100 peptide vaccines administered subcutaneously. Immune reactivity to the gp100 epitope peptides will be monitored in all patients by analysis of melanoma-specific T cell precursor frequency prior to and after immunization.

Conditions

Melanoma

Keywords

Cancer; Immunotherapy

Interventions

gp100 human melanoma peptide BIOLOGICAL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Metastatic melanoma that is HLA-A2 positive. No primary melanoma of ocular or mucosal origin. Measurable or resected metastatic disease required. PRIOR/CONCURRENT THERAPY: BIOLOGIC THERAPY: No prior (greater than 30 days) or concurrent Biologic Therapy. CHEMOTHERAPY: No prior (greater than 30 days) or concurrent chemotherapy. ENDOCRINE THERAPY: No prior (greater than 30 days) or concurrent hormone therapy. No requirement for steroids. RADIOTHERAPY: No prior (greater than 30 days) or concurrent radiotherapy. SURGERY: Not specified. PATIENT CHARACTERISTICS: Age: 18 and over. Performance Status: ECOG 0 or 1. Life Expectancy: More than 3 months. HEMATOPOIETIC: No coagulation disorder. HEPATIC: Bilirubin no greater than 2.0 mg/dL. No Hepatitis BsAg antibody. RENAL: Creatinine no greater than 2.0 mg/dL. CARDIOVASCULAR: No major cardiovascular illness. PULMONARY: No major respiratory illness. OTHER: No previous allergic reaction to incomplete Freund's adjuvant. HIV negative. No active systemic infection. Not pregnant or lactating.

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Rosenberg SA. Cancer vaccines based on the identification of genes encoding cancer regression antigens. Immunol Today. 1997 Apr;18(4):175-82. doi: 10.1016/s0167-5699(97)84664-6. No abstract available.

  PMID: 9136454 BACKGROUND

• Rosenberg SA. Development of cancer immunotherapies based on identification of the genes encoding cancer regression antigens. J Natl Cancer Inst. 1996 Nov 20;88(22):1635-44. doi: 10.1093/jnci/88.22.1635.

  PMID: 8931607 BACKGROUND

• Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL, Restifo NP, Dudley ME, Schwarz SL, Spiess PJ, Wunderlich JR, Parkhurst MR, Kawakami Y, Seipp CA, Einhorn JH, White DE. Immunologic and therapeutic evaluation of a synthetic peptide vaccine for the treatment of patients with metastatic melanoma. Nat Med. 1998 Mar;4(3):321-7. doi: 10.1038/nm0398-321.

  PMID: 9500606 BACKGROUND

MeSH Terms

Conditions

Melanoma; Neoplasms

Interventions

PMEL protein, human

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: December 10, 2002
• Study Start: June 1, 1995
• Study Completion: April 1, 2000
• Last Updated: March 4, 2008

Record last verified: 1999-05

Locations

US (1)