Ensayos clínicos

Study closed to enrollment

Inclusion Criteria:

• Central pathology review submission; this review for MART-1 positivity is mandatory prior to registration to confirm eligibility
• Human leukocyte antigen (HLA)-A2-positive
• Histologic proof of stage II, III or IV melanoma that has been completely resected with no current evidence of disease, as demonstrated by imaging within 2 months (stage III or stage IV; must be computed tomography [CT], magnetic resonance imaging [MRI], or positron emission tomography [PET]/CT) or 6 months (stage II; may be chest x-ray, CT, MRI, or PET/CT)
• Absolute neutrophil count (ANC) ≥ 1500 mL
• Hemoglobin (Hgb) > 10 g/dL
• Platelets (PLT) ≥ 50,000 mL
• Aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN)
• Alkaline phosphatase ≤ 3 x ULN
• Ability to provide informed consent
• Willingness to return to Mayo Clinic Rochester for follow-up
• Life expectancy ≥ 12 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
• For women of childbearing potential, a negative serum pregnancy test ≤ 7 days prior to registration
• Willingness to provide mandatory blood samples for correlative research

Exclusion Criteria:

• Uncontrolled or current infection
• Known standard therapy for the patient's disease that is potentially curative or proven capable of extending life expectancy
• Known allergy to vaccine or adjuvant components
• Any of the following prior therapies with interval since most recent treatment:
  • Chemotherapy ≤ 4 weeks prior to registration
  • Biologic therapy or immunotherapy ≤ 4 weeks prior to registration
  • Radiation therapy ≤ 4 weeks prior to registration
• Failure to fully recover from side effects of prior chemotherapy or surgery
• Any of the following, as this regimen may be harmful to a developing fetus or nursing child:
  • Pregnant women
  • Nursing women
  • Women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.)
• Known immune deficiency, including human immunodeficiency virus (HIV) infection, as patients with known immune deficiencies will likely not be able to mount an immune response to the study vaccine; in addition, study patients should be naive to the HIV-derived Gag267-274 antigen
• History of systemic autoimmune disease, as patients with ongoing autoimmunity may be at an increased risk of autoimmune toxicity from the study vaccine
• Current or recent (≤ 4 weeks prior to registration) use of immunosuppressive medications including systemic corticosteroids; (use of corticosteroids in doses not exceeding those used for adrenal replacement is acceptable)
• History of brain metastases (even if completely resected)
• Other active malignancy ≤ 5 years prior to registration; EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: If there is a history or prior malignancy, they must not be receiving other treatment for their cancer