Completed

Immunization Of Patients With Metastatic Melanoma Using A Recombinant GP100 Protein (184V) And A Class I Restricted Peptide From The GP100 Antigen

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What is being tested

Data Collection

Who is being recruted

Melanoma
+8

+ Neoplasms
+ Neoplasms by Histologic Type
Over 16 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 2003
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2003Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Compare the clinical response in patients with metastatic melanoma immunized with recombinant gp100 protein (184V) emulsified in Montanide ISA-51 with or without gp100:209-217 (210M) peptide. Secondary * Compare the toxicity profile of these immunizations in these patients. OUTLINE: This is a randomized study. Patients are assigned to 1 of 2 cohorts according to HLA-A2\*0201 status. Patients assigned to cohort 1 are then randomized to 1 of 2 treatment arms. * Cohort 1 (HLA-A2\*0201-positive patients): Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive immunization comprising recombinant gp100 protein (184V) emulsified in Montanide ISA-51 subcutaneously (SC) on days 1, 22, 43, and 64 (1 course). * Arm II: Patients receive immunization comprising recombinant gp100 protein (184V) and gp100:209-217 (210M) peptide emulsified in Montanide ISA-51 SC on days 1, 22, 43, and 64 (1 course). * Cohort 2 (HLA-A2\*0201-negative patients): Patients receive immunization as in cohort 1, arm I. In both cohorts, treatment continues in the absence of rapid disease progression or unacceptable toxicity. In both cohorts, patients are evaluated 3-4 weeks after the fourth immunization. Patients achieving stable disease or a partial response receive retreatment according to their assigned cohort. Patients with progressive disease who are eligible for interleukin-2 (IL-2) receive retreatment according to their assigned cohort AND high-dose IL-2 IV over 15 minutes 3 times daily on days 2-5, 23-26, 44-47, and 65-68 (1 course). Patients receive up to 3 retreatment courses. Patients achieving a complete response (CR) receive 1 retreatment course beyond CR. Patients with progressive disease who are ineligible for IL-2 administration are removed from the study. PROJECTED ACCRUAL: A total of 45-75 patients (30-50 for cohort 1 \[15-25 per treatment arm\] and 15-25 for cohort 2) will be accrued for this study within 3 years.

Official TitleImmunization Of Patients With Metastatic Melanoma Using A Recombinant GP100 Protein (184V) And A Class I Restricted Peptide From The GP100 Antigen 
NCT00069043NCT00072085
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 16 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Skin Diseases
Skin Neoplasms
Neuroectodermal Tumors
Nevi and Melanomas
Neuroendocrine Tumors
Criteria

DISEASE CHARACTERISTICS: * Diagnosis of metastatic melanoma * Measurable disease * Progressive disease during or after prior standard treatment with or without interleukin-2 PATIENT CHARACTERISTICS: Age * 16 and over Performance status * ECOG 0-2 Life expectancy * More than 6 months Hematopoietic * WBC at least 3,000/mm\^3 * Platelet count at least 90,000/mm\^3 * Lymphocyte count greater than 500/mm\^3 Hepatic * Bilirubin no greater than 2.0 mg/dL (less than 3.0 mg/dL for patients with Gilbert's syndrome) * ALT and AST less than 3 times normal * Hepatitis B surface antigen negative Renal * Creatinine no greater than 2.0 mg/dL Cardiovascular * No symptomatic cardiac disease Immunologic * No active systemic infection * No autoimmune disease * No known immunodeficiency disease * No known hypersensitivity to study agents * No form of primary or secondary immunodeficiency * No opportunistic infection * HIV negative Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * No prior gp100 peptide vaccine Chemotherapy * More than 6 weeks since prior nitrosoureas Endocrine therapy * No concurrent systemic steroid therapy Radiotherapy * Not specified Surgery * Prior recent (within the past 3 weeks) minor surgical procedures allowed Other * Recovered from prior therapy (toxicity no greater than grade 1) * More than 3 weeks since prior systemic anticancer therapy * No other concurrent systemic anticancer therapy

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 2 locations
Suspended
Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, United StatesSee the location
Suspended
NCI - Center for Cancer ResearchBethesda, United States
Completed2 Study Centers