Ensayos clínicos

Inclusion Criteria

• 18 years or older
• Eastern Cooperative Oncology Group (ECOG) performance status 0,1
• AJCC stage III or IV completely resectable melanoma identified before surgery
• Approximately 1 mg (1 cm3) of accessible and dispensable tumor that will not interfere with pathologic staging
• Clinically disease-free after surgery
• Completing SoC adjuvant therapy per NCCN guidelines to include chemotherapy, radiation therapy, and/or biologic therapy as clinically indicated (Consent #2 should be signed as close to completion of SoC as possible but may overlap completion by up to one month.)
• Vaccinations initiated between 3 weeks and 3 months from completion of SoC multi-modality cancer care
• Adequate organ function as determined by the following laboratory values
  • ANC ≥ 1,000/μL
  • Platelets ≥ 75,000/μL
  • Hgb ≥ 9 g/dL
  • Creatinine ≤ 1.5 x upper limit of normal (ULN) or Creatinine clearance ≥ 50%
  • Total bilirubin ≤ 1.5 ULN
  • ALT and AST ≤ 1.5 ULN
• For women of child-bearing potential, agreement to use adequate birth control (abstinence, hysterectomy, bilateral oophorectomy, bilateral tubal ligation, oral contraception, IUD, or use of condoms or diaphragms)
• Signed informed consent

Exclusion Criteria

• Evidence of residual disease after surgery and SoC adjuvant therapies
• Insufficient tumor available to produce vaccine
• ECOG >2 performance status
• Immune deficiency disease or known history of HIV, HBV, HCV
• Receiving immunosuppressive therapy including chronic steroids, methotrexate, or other known immunosuppressive agents
• Pregnancy (assessed by urine HCG)
• Breast feeding
• Active pulmonary disease requiring medication to include multiple inhalers (>2 inhalers and one containing steroids)
• Involved in other experimental protocols (except with permission of the other study PI)