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, 2003

Actual 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.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 12 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

MelanomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueSkin DiseasesSkin NeoplasmsNeuroectodermal TumorsNevi and MelanomasNeuroendocrine 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 Center

Washington, United StatesSee the location
Suspended

Fox Chase Cancer Center

Philadelphia, United States
Suspended

Hillman Cancer Center at University of Pittsburgh Cancer Institute

Pittsburgh, United States
Suspended

MD Anderson Cancer Center at University of Texas

Houston, United States
Completed5 Study Centers