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

Tracking Information
First Received Date ^ICMJE	November 3, 1999
Last Updated Date	March 3, 2008
Start Date ^ICMJE	June 1995
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00001439 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Phase I Study of gp100 Human Melanoma Peptide Vaccine With Incomplete Freund's Adjuvant
Official Title ^ICMJE	A Phase I Study of gp100 Human Melanoma Peptide Vaccine With Incomplete Freund's Adjuvant
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.
Detailed 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 immunization.
Study Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Safety Study
Condition ^ICMJE	Melanoma
Intervention ^ICMJE	Biological: gp100 human melanoma peptide
Study Arms / Comparison Groups
Publications *	Rosenberg SA. Cancer vaccines based on the identification of genes encoding cancer regression antigens. Immunol Today. 1997 Apr;18(4):175-82. Review. No abstract available. 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. Review. 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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	255
Completion Date	April 2000
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00001439
Responsible Party
Study ID Numbers ^ICMJE	950145, 95-C-0145
Study Sponsor ^ICMJE	National Cancer Institute (NCI)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	May 1999
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP