Vaccine Therapy in Treating HLA-A2 Positive Patients With Melanoma
Condition: Recurrent Melanoma; Stage IA Melanoma; Stage IB Melanoma; Stage IIA Melanoma; Stage IIB Melanoma; Stage IIC Melanoma; Stage IIIA Melanoma; Stage IIIB Melanoma; Stage IIIC Melanoma
MeSH terms: Melanoma
Intervention: HPV 16 E7:12-20; gp100:209-217(210M); laboratory biomarker analysis
Intervention description: Given SC; Given SC; Correlative studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 17 Years
Healthy volunteers: No

Summary:

      This randomized pilot phase II trial studies how well vaccine therapy works in treating human
      leukocyte antigen class 1 histocompatibility, A-2 (HLA-A2) positive patients with melanoma.
      Vaccines made from peptides may help the body build an effective immune response to kill
      tumor cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically confirmed primary melanoma of Breslow thickness
             1.0-4.0 mm; patients who have had only their initial biopsy are preferred; however,
             those who have already undergone a wide local excision are also eligible; patients may
             be enrolled up to three months after their wide local excision

          -  Patients whose melanoma is > 4.0 mm thick who have positive or negative regional lymph
             nodes are also eligible

          -  After accrual to the original 26 patient goal, all patients must be enrolled prior to
             sentinel lymph node dissection; patients with previous lymph node dissection will not
             be eligible

          -  Patients must be HLA typed and be shown to be HLA-A2.1+ by either serologic
             techniques, flow cytometry, or molecular techniques

          -  Patients must be ambulatory with good performance status (Karnofsky performance status
             [PS] 80-100)

          -  White blood cell (WBC) >= 3500/mm^3

          -  Platelets (Plt) >= 100,000/mm^3

          -  Hemoglobin >= 9 gm/100 ml

          -  Serum creatinine =< 2 mg/dl

          -  Total bilirubin =< 2.0 mg/dl

          -  Patients must have recovered from any effects of major surgery and be free of
             significant systemic infection

          -  Patients must be negative for human immunodeficiency virus (HIV) antibody by
             enzyme-linked immunosorbent assay (ELISA) (or negative by Western blot if ELISA is
             positive) if they are considered to be at high risk; others do not require serologic
             testing if there are no symptoms or risk factors for HIV disease

          -  Women of childbearing potential must have a negative pregnancy test and should avoid
             becoming pregnant while on treatment

          -  Patients must give written informed consent prior to initiation of therapy; patients
             with a history of major psychiatric illness must be judged able to fully understand
             the investigational nature of the study and the risks associated with the therapy

        Exclusion Criteria:

          -  Patients must not have clinically detectable distant metastases

          -  Patients who require or are likely to require systemic corticosteroids for
             intercurrent illness

          -  Patients with any significant medical disease other than the malignancy (e.g. chronic
             obstructive pulmonary disorder [COPD], patients with ascites or pleural effusions)
             which in the opinion of the investigator would significantly increase the risk of
             immunotherapy

          -  Patient should be free of any other cancers or deemed at low risk for their recurrence