Completed

Evaluation of GM-CSF-in-Adjuvant and the Number of Vaccine Sites on Immunization With Multiple Synthetic Melanoma Peptides

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What is being tested

Data Collection

Who is being recruted

Melanoma
+8

+ Neoplasms
+ Neoplasms by Histologic Type
Over 12 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 2003
See protocol details

Summary

Principal SponsorCraig L Slingluff, Jr
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: * Compare immune response in patients with stage IIB-IV melanoma treated with vaccination comprising multiple synthetic melanoma peptides and Montanide ISA-51 with vs without sargramostim (GM-CSF). * Compare immune response in patients treated with these vaccinations administered at 1 vs 2 sites. OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 4 treatment arms. * Arm I: Patients receive vaccination comprising multiple synthetic melanoma peptides and Montanide ISA-51 at 1 injection site. * Arm II: Patients receive vaccination comprising multiple synthetic melanoma peptides and Montanide ISA-51 at 2 injection sites. * Arm III: Patients receive vaccination comprising multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF) at 1 injection site. * Arm IV: Patients receive vaccination comprising multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF at 2 injection sites. In all arms, treatment repeats once weekly for 6 weeks. Patients return for booster vaccinations at weeks 12, 26, 39, and 52. PROJECTED ACCRUAL: A maximum of 124 patients will be accrued for this study.

Official TitleEvaluation of GM-CSF-in-Adjuvant and the Number of Vaccine Sites on Immunization With Multiple Synthetic Melanoma Peptides 
NCT00089193
Principal SponsorCraig L Slingluff, Jr
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.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

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 12 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 melanoma * Stage IIB, IIC, III, or IV disease * Must express HLA-A1, -A2, or -A3 * No ocular melanoma PATIENT CHARACTERISTICS: Age * 12 and over Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count \> 1,000/mm\^3 * Platelet count \> 100,000/mm\^3 * Hemoglobin \> 9 g/dL Hepatic * Liver function tests ≤ 2.5 times upper limit of normal (ULN) Renal * Creatinine ≤ 1.5 times ULN Cardiovascular * No New York Heart Association class III or IV heart disease Other * Not pregnant or nursing * No other malignancy within the past 5 years except basal cell or squamous cell skin cancer without brain metastasis, carcinoma in situ of the breast, or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * More than 4 weeks since prior immunotherapy * More than 4 weeks since prior growth factors * More than 4 weeks since prior allergy shots * No prior vaccine therapy for melanoma or any other cancer with any of the peptides used in this study * More than 12 weeks since prior melanoma vaccine therapy\* NOTE: \*Prior melanoma vaccine allowed only for patients with disease progression during or after administration of the vaccine Chemotherapy * More than 4 weeks since prior chemotherapy Endocrine therapy * More than 4 weeks since prior steroids Radiotherapy * More than 4 weeks since prior radiotherapy Surgery * Not specified



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 5 locations
Suspended
Washington Cancer Institute at Washington Hospital CenterWashington, United StatesSee the location
Suspended
Fox Chase Cancer CenterPhiladelphia, United States
Suspended
Hillman Cancer Center at University of Pittsburgh Cancer InstitutePittsburgh, United States
Suspended
MD Anderson Cancer Center at University of TexasHouston, United States

Completed5 Study Centers
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