Search / Trial NCT00001439

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

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

Trial Information

Current as of December 08, 2024

Completed

Keywords

Cancer Immunotherapy

ClinConnect 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 immun...

Gender

ALL

Eligibility criteria

  • 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.

About National Cancer Institute (Nci)

The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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