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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

255 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-06-30

Study Completion Date

2000-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma

NCT00019448

Stage IV Melanoma Recurrent Melanoma

COMPLETED PHASE2

Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma

NCT00019214

Melanoma (Skin)

COMPLETED PHASE1/PHASE2

Vaccine Therapy in Treating Patients With Metastatic Melanoma

NCT00019994

Melanoma (Skin)

COMPLETED PHASE2

Immunization of Patients With Metastatic Melanoma Using the GP100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence

NCT00001705

Melanoma Neoplasm Metastasis

COMPLETED PHASE2

Immunization of HLA-A201 Patients With Metastatic Melanoma Using a Combination of Immunodominant Peptides From Three Melanoma Antigens, MART-1, GP100 and Tyrosinase

NCT00001685

Melanoma Neoplasm Metastasis

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Melanoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

gp100 human melanoma peptide

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No