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Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery

Vaccination With Synthetic Melanoma Peptides Administered With GM-CSF-in-Adjuvant in Patients With Advanced Melanoma

NCT00089206•University of Virginia

View on ClinicalTrials.gov

Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery.

Detailed Description

OBJECTIVES: * Determine the antitumor immune response in patients with unresectable stage III or IV melanoma treated with vaccine comprising multiple synthetic melanoma peptides, sargramostim (GM-CSF), and Montanide ISA-51. OUTLINE: Patients receive vaccine comprising multiple synthetic melanoma peptides, sargramostim (GM-CSF), and Montanide ISA-51 on days 1, 8, 15, 29, 36, and 43. Patients undergo removal of the lymph node draining the vaccination site on day 22 to assess immune response. PROJECTED ACCRUAL: A maximum of 29 patients will be accrued for this study.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•DISEASE CHARACTERISTICS:
•Diagnosis of melanoma
•* Unresectable stage III or IV disease
•* Mucosal or ocular disease allowed
•Positive HLA-A1, -A2, or -A3 expression
•PATIENT CHARACTERISTICS:
•Age
•12 and over
•Performance status
•ECOG 0-1
+31 more criteria

Locations (1)

Cancer Center at the University of Virginia

Charlottesville, Virginia, United States

Key Dates

Start Date

August 1, 2002

Primary Completion Date

November 1, 2005

Last Updated

December 19, 2014

Enrollment

ACTUAL participants

Conditions

Intraocular MelanomaMelanoma (Skin)

Interventions

incomplete Freund's adjuvant

BIOLOGICAL

multi-epitope melanoma peptide vaccine

BIOLOGICAL

sargramostim

BIOLOGICAL

Evaluation of the Safety, Efficacy, and Pharmacokinetics of NBM-BMX in Patients With Metastatic Uveal Melanoma

NCT07136181

Metastatic Uveal MelanomaUveal Melanoma, Metastatic+3 more

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RECRUITINGPHASE3

Adjuvant Melatonin for Uveal Melanoma

NCT05502900

Uveal MelanomaUveal Melanoma, Posterior, Medium/Large Size+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 19, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery

Inclusion Criteria

Evaluation of the Safety, Efficacy, and Pharmacokinetics of NBM-BMX in Patients With Metastatic Uveal Melanoma

Adjuvant Melatonin for Uveal Melanoma

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A Prospective Observational Study on Targeted Therapy for Unresectable or Metastatic BRAFV600E Mutant Melanoma Patients

Pembrolizumab and EDP1503 in Advanced Melanoma

FAPi Radioligand OpeN-Label, Phase 1 Study to Evaluate Safety, Tolerability and DosImetry of [Lu-177]-PNT6555; A Dose Escalation Study for TReatment of Patients With Select Solid Tumors (FRONTIER)