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

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Trial Information

Current as of May 23, 2024

Completed

Keywords

Cancer Immunotherapy

Description

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.

Attachments

readout_NCT00001439_2024-05-23.pdf

4.5 MB

NCT00001439_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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