Aldesleukin With or Without Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Melanoma
Condition: Recurrent Melanoma; Stage IIIA Skin Melanoma; Stage IIIB Skin Melanoma; Stage IIIC Skin Melanoma; Stage IV Skin Melanoma
MeSH terms: Melanoma; Skin Neoplasms
Intervention: Aldesleukin; gp100 Antigen; Montanide ISA 51 VG; Quality-of-Life Assessment; Questionnaire Administration; Laboratory Biomarker Analysis
Intervention description: Given IV; Given SC; Given SC; Ancillary studies; Ancillary studies; Correlative studies
Intervention MeSH terms: Aldesleukin; Monatide (IMS 3015)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 185.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase III trial studies aldesleukin with vaccine therapy to see how well it
      works compared to aldesleukin alone in treating patients with melanoma that has spread from
      where it started to nearby tissue or lymph nodes or to other places in the body. Aldesleukin
      may stimulate a person's white blood cells to kill melanoma cells. Vaccines may make the body
      build an immune response to kill tumor cells. It is not yet known whether combining
      aldesleukin with vaccine therapy is more effective than aldesleukin alone in treating
      melanoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any patient with measurable metastatic (stage IV or locally advanced stage III)
             cutaneous melanoma and an expected survival of greater than three months will be
             considered

          -  Serum creatinine of 1.6 mg/dl or less

          -  Total bilirubin 1.6 mg/dl or less

          -  White blood cell (WBC) 3000/mm^3 or greater

          -  Platelet count 90,000 mm^3 or greater

          -  Serum aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less then three
             times normal

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Patients of both genders must be willing to practice effective birth control during
             this trial

          -  Pathologic confirmation of cutaneous melanoma; patients may enter the study with a
             pathologic diagnosis of cutaneous melanoma from any institution; all slides will be
             reviewed at National Institutes of Health (NIH) (department of Anatomic Pathology) and
             if the diagnosis is not confirmed, the patient will be excluded from the study

          -  Tissue type human leukocyte antigen (HLA) A0201

        Exclusion Criteria:

          -  Patients who have types of melanoma other than cutaneous, i.e. ocular or mucosal

          -  Patients who are undergoing or have undergone in the past 4 weeks any other form of
             therapy except surgery for their cancer, including radiation therapy to any site

          -  Patients who have active systemic infections, coagulation disorders, autoimmune
             disease or history of other major medical illnesses such as insulin dependent diabetes
             mellitus, cardiac ischemia, myocardial infarction, cardiac arrhythmias, obstructive or
             restrictive pulmonary diseases and inflammatory bowel disorders

          -  Patients who have significant psychiatric disease which in the opinion of the
             principal investigator would prevent adequate informed consent or render immunotherapy
             unsafe or contraindicated

          -  Patients who require steroid therapy or steroid-containing compounds, or have used
             systemic steroids in the past 4 weeks, or have used topical or inhalational steroids
             in the past 2 weeks

          -  Patients who are pregnant

          -  Patients who are known to be positive for viral hepatitis B or C (hepatitis B surface
             antigen [HBsAg] or anti hepatitis C virus [HCV]) or human immunodeficiency virus (HIV)
             (HIV antibody)

          -  Patients who have any form of primary or secondary immunodeficiency

          -  Patients who have received previous high dose IL-2 (> 600,000 IU/kg)

          -  Patients who have received previous gp100 vaccines

          -  Patients who have an abnormal stress cardiac test (stress thallium, stress multi gated
             acquisition scan [MUGA], dobutamine echocardiogram or other stress test that will rule
             out cardiac ischemia)

          -  Patients who have abnormal pulmonary function tests (forced expiratory volume in one
             second [FEV1] < 65% or forced vital capacity [FVC] < 65% of predicted)

          -  Patients who have brain metastasis or history of brain metastasis

          -  No prior malignancy is allowed except for adequately treated basal cell or squamous
             cell skin cancer, in situ cervical cancer, or other cancer for which the patient has
             been disease free for 5 years