A Multipeptide Vaccine Plus Toll-Like Receptor Agonists in Melanoma Patients

You may be eligible if

• Histologically or cytologically proven melanoma that meets one of the following two criteria:
• * Stage IIB-IV melanoma rendered clinically free of disease by surgery, other therapy, or spontaneous remission within 6 months prior to registration.
• * The total number of brain metastases ever is less than or equal to 3.
• * The brain metastases have been completely removed by surgery or have been treated completely by stereotactic radiotherapy. Stereotactic radiotherapy, such as gamma knife, can be used up to 1 week prior to study entry.
• * There has been no evident growth of any brain metastasis since treatment.
• * No treated brain metastasis is greater than 2 cm in diameter at the time of protocol entry.
• Patients must have at least two intact axillary and/or inguinal lymph node basins.
• All patients must have:
• * ECOG performance status of 0 or 1.
• * Ability and willingness to give informed consent.
• Laboratory parameters as follows:
• * HLA-A1, A2, A3, -A11, or -A31
• * ANC \> 1000/mm3
• * Platelets \> 100,000/mm3
• * Hgb ≥ 9 g/dL
• * AST and ALT ≤ 2.5 x upper limits of normal (ULN)
• * Bilirubin ≤ 2.5 x ULN
• * Alkaline Phosphatase ≤ 2.5 x ULN
• * Creatinine ≤ 1.5 x ULN
• * HIV negative
• * Hepatitis C negative
• * HGBA1C level of \< 7%
• Patients who are currently receiving systemic cytotoxic chemotherapy, radiation, or other experimental therapy, or who have received this therapy within the preceding 4 weeks. Gamma knife or stereotactic radiosurgery may be administered within the prior 4 weeks, but must not be administered less than one week prior to study enrollment. Patients who are currently receiving nitrosoureas or who have received this therapy within the preceding 6 weeks.
• Patients with clinically detectable melanoma deemed likely by the investigator to require intervention during the first 12 weeks of the study that would require premature discontinuation.
• Patients with known or suspected allergies to any component of the vaccine.
• Patients receiving the following medications at study entry or within the preceding 4 weeks are excluded:
• * Agents with putative immunomodulating activity (with the exception of non-steroidal anti-inflammatory agents and topical steroids
• * Allergy desensitization injections.
• * Systemic corticosteroids, administered parenterally or orally. Inhaled steroids (e.g. Advair®, Flovent®, Azmacort®) are not permitted. Topical corticosteroids are acceptable, including steroids with very low solubility administered nasally for local effects only (e.g. Nasonex®).
• * Any growth factors (e.g. GM-CSF, G-CSF, erythropoietin).
• * Interferon therapy.
• * Interleukin-2 or other interleukins.
• * Toll-like receptor agonists, including imiquimod or resiquimod.
• Prior melanoma vaccinations may be an exclusion criterion in some circumstances:
• * Patients who have recurred or progressed either after or during administration of a melanoma vaccine may be eligible to enroll 12 weeks following their last vaccination.
• * Patients may have been vaccinated previously with peptide vaccines (except that they may not have been vaccinated with peptides included in MELITAC 12.1 or MELITAC 12.6)
• * Patients may have been vaccinated with protein, DNA, or cell-based vaccines that include the proteins from which these peptides are derived.
• Other investigational drugs or investigational therapy if the patient is currently taking those drugs/therapy, or if they have received the drugs/therapy within 1 month.
• Pregnancy or the possibility of becoming pregnant during vaccine administration. Women must also not be breast feeding.
• 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 as having Class III or IV heart disease according to the New York Heart Association
• Body weight \< 110 lbs
• No active or prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement. The following will not be exclusionary:
• * The presence of laboratory evidence of autoimmune disease (e.g. positive ANA titer) without associated symptoms
• * Clinical evidence of vitiligo
• * Other forms of depigmenting illness
• * Mild arthritis requiring NSAID medications or no medical therapy