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 (MEL36)

This is an interventional treatment trial for Melanoma focused on measuring melanoma, vaccine, peptides, adjuvant, immunogenicity, stage IIB, stage III or resected stage IV Read More

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.