Trial for the Evaluation of the Effect of Systemic Low-dose Interleukin-2 (IL-2) on the Immunogenicity of a Vaccine Comprising Synthetic Melanoma Peptides Administered With Granulocyte-macrophage Colony-stimulating Factor (GM-CSF)-In-Adjuvant, in Patients With High Risk Melanoma

Pilot Phase II Trial for the Evaluation of the Effect of Systemic Low-dose IL-2 on the Immunogenicity of a Vaccine Comprising Synthetic Melanoma Peptides Administered With GM-CSF-in-Adjuvant, in Patients With High Risk Melanoma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00928902

Acronym

MEL36

Enrollment

Registered

2009-06-26

Start date

1999-11-30

Completion date

2005-03-31

Last updated

2010-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Keywords

melanoma, vaccine, peptides, adjuvant, immunogenicity, stage IIB, stage III or resected stage IV

Brief summary

This clinical pilot study will test the hypothesis that systemic low-dose IL-2 therapy significantly enhances the immunologic efficacy of a vaccine comprising melanoma peptides plus GM-CSF-in-adjuvant.

Interventions

DRUGlow-dose IL-2

low-dose IL-2, administered daily for 6 weeks, to begin either at week 1 (group 1) or week 4 (group 2)

BIOLOGICALmelanoma vaccine

six melanoma vaccines given over a 6-week period

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Patients who have been diagnosed, by cytologic or histologic examination, with AJCC stage IIB, stage III or resected stage IV melanoma. * Patients with up to 2 brain metastases less than or equal to 2 cm that have been surgically removed or treated successfully with the gamma-knife are eligible. Surgical resections must have been performed within 6 months prior to entry. * All patients must have: 1. ECOG performance status 0-1, and, 2. Ability and willingness to give informed consent. * Laboratory parameters as follows: * HLA-A1, A2 or A3 (+) * gp100 (+) and/or tyrosinase (+) tumor cells * ANC \> 1000/mm3, and Platelets \> 100,000 and Hgb \> 9 * Hepatic: AST and ALT up to 2.5 x upper limits of normal (ULN), Bilirubin up to 2.5 x ULN, Alkaline phosphatase up to 2.5 x ULN * Renal: Creatinine up to 1.5 x ULN * Serology: HIV negative, Hepatitis C negative

Exclusion criteria

* Patients who are currently receiving cytotoxic Chemotherapy or radiation or who have received that therapy within the preceding 4 weeks. * Patients with known or suspected allergies to any component of the vaccine. * Patients receiving the following medications at study entry or within the preceding 30 days are excluded: * Agents with putative immunomodulating activity (with the exception of non-steroidal anti-inflammatory agents) * Allergy desensitization injections * Corticosteroids, administered parenterally or orally - topical corticosteroids are acceptable * Any growth factors, Interleukin 2, Interferon alfa. * Prior melanoma vaccinations will not be an

Design outcomes

Primary

Measure	Time frame
To evaluate the effect of systemic low-dose IL-2 on the immunogenicity of a vaccine comprising synthetic melanoma peptides plus GM-CSF-in-adjuvant.	—

Secondary

Measure	Time frame
Changes in disease, analysis of melanoma antigen (gp100, tyrosinase, MART-1) expression on melanoma cells from metastatic sites, Vitiligo.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026