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

Conditions: Melanoma

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.


Eligibility criteria:
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 exclusion criteria if given more than 8 weeks previously, but will be recorded, and data analysis will take this into account. * other investigational drugs or investigational therapy also will not necessarily be an exclusion criteria, but will similarly be recorded and taken into account during data analysis. * pregnancy or the possibility of becoming pregnant during vaccine administration. * female patients of child-bearing potential must have a negative pregnancy test (urinary or serum beta-hcg) prior to administration of the first vaccine dose. * males and females must agree, in the consent form, to use effective birth control methods during the course of vaccination. * this is consistent with existing standards of practice for vaccine and chemotherapy protocols. * patients in whom there is a medical contraindication or potential problem in complying with the requirements of the protocol, in the opinion of the investigator. * patients classified according to the new york heart association classification system as having class ii, iii or iv heart disease. * patients with active connective tissue disease requiring medication, or other severe autoimmune disease. * patients who are actively hyperthyroid. * patients with uncontrolled diabetes.

Keywords: melanoma vaccine peptides adjuvant immunogenicity stage iib, stage iii or resected stage iv