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Cancer Vaccine

Peptides pulsed on dendritic cells for Skin Cancer

Phase 2
Waitlist Available
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 0-6,12; months 6,12 and 24
Awards & highlights

Summary

RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to and kill tumor cells. Colony-stimulating factors such as GM-CSF may increase the number of immune cells found in the bone marrow or peripheral blood. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. Combining vaccine therapy with GM-CSF and interleukin-2 may be kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of vaccines made from melanoma cells with or without GM-CSF followed by interleukin-2 in treating patients with stage III or stage IV melanoma.

Eligible Conditions
  • Skin Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 0-6,12; months 6,12 and 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 0-6,12; months 6,12 and 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluation of Objective Clinical Response (CR/PR/SD)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Peptides pulsed on dendritic cellsExperimental Treatment5 Interventions
4 melanoma peptides pulsed on monocyte-derived dendritic cells
Group II: Peptides in GMCSF-in-adjuvantExperimental Treatment6 Interventions
4 melanoma peptides administered as an emulsion with GM-CSF and Montanide ISA-51 adjuvant.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
incomplete Freund's adjuvant
2005
Completed Phase 2
~620
Sargramostim
FDA approved
Tyrosinase
Not yet FDA approved
tetanus peptide melanoma vaccine
2005
Completed Phase 2
~220
Aldesleukin
FDA approved
GP-100 antigen
Not yet FDA approved

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
771 Previous Clinical Trials
1,284,257 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,841 Previous Clinical Trials
41,002,775 Total Patients Enrolled
Craig L. Slingluff, MDStudy ChairUniversity of Virginia
8 Previous Clinical Trials
458 Total Patients Enrolled
~1 spots leftby Sep 2025
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