Aldesleukin With or Without Vaccine Therapy in Treating Patients With Stage IV Melanoma
Condition: Stage IV Melanoma
MeSH terms: Melanoma
Intervention: aldesleukin; allogeneic large multivalent immunogen vaccine
Intervention description: IL-2 Alone - administer 10 x 10^6 International Units subcutaneously (SQ) will be given on day 1 and day 2 every 4 weeks until disease progression or for a maximum of 12 treatment cycles.; Allogeneic tumor cell membrane-coated large multivalent immunogen (LMI [1 x 10^7, 5-μm silica spheres]) will be given as an intradermal injection every 4 weeks for up to 12 injections. Each vaccine dose will be 0.2 ml.
Intervention MeSH terms: Aldesleukin; Interleukin-2; Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent melanoma

Summary:

      RATIONALE: Aldesleukin may stimulate the white blood cells to kill tumor cells. Vaccines may
      help the body build an effective immune response to kill tumor cells. Giving aldesleukin
      together with vaccine therapy may kill more tumor cells. It is not yet known whether
      aldesleukin is more effective with or without vaccine therapy in treating melanoma.

      PURPOSE: This randomized phase II trial is studying how well aldesleukin works when given
      with or without vaccine therapy in treating patients with stage IV melanoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stage IV melanoma.

          -  Prior systemic chemotherapy, immunotherapy, or biological therapy is allowed if at
             least 4 weeks since last treatment. Patient must recover from the acute toxic effects
             of the treatment prior to study enrollment.

          -  Disease status must be that of measurable or nonmeasurable disease as defined by Solid
             Tumor Response Criteria (RECIST)

          -  Karnofsky performance status >70% (Eastern Cooperative Oncology Group 0-1)

          -  Age 18 years or older

          -  Adequate organ function within 14 days of study enrollment including the following:

               -  Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count
                  (ANC) ≥ 1.5 x 10^9/L, platelets ≥100 x 10^9/L, and hemoglobin ≥ 10 g/dL

               -  Hepatic: bilirubin < 3 times the upper limit of normal (× ULN), aspartate
                  transaminase (AST) < 3 × ULN

               -  Renal: creatinine ≤ 2.0

          -  Must share at least one class I HLA allele with the HLA-type SK23-CD80+ cell (class I
             alleles (A1, A2, B7, B8, C7))

          -  Meets eligibility criteria for and agrees to enroll in "MT1999- 06: Vaccination with
             Tetanus Toxoid and Keyhole Limpet Hemocyanin (KLH) to Assess Antigen-Specific Immune
             Responses" (IRB # 9904M01581, CPRC #2002LS032)

          -  Women of childbearing potential and men whose partners are of childbearing potential
             are required to use an effective method of contraception (ie, a hormonal
             contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide,
             or abstinence) during the study and for 3 months after the last dose of study drug.

          -  Voluntary written informed consent before performance of any study-related procedure
             not part of normal medical care, with the understanding that consent may be withdrawn
             by the subject at any time without prejudice to future medical care.

        Exclusion criteria:

          -  History of brain metastases or positive brain scan at on-study

          -  Immunosuppressive therapy i.e., prednisone or organ transplant patients, however
             topical or inhalational steroids are allowed.

          -  Autoimmune diseases requiring immunosuppressive therapy.

          -  History of symptomatic pulmonary disease will have pulmonary function tests (PFTs)
             performed. Patients with symptoms of dyspnea or rales, wheezes or rhonchi on physical
             exam will undergo PFTs. Those with FEV1 <50% of predicted or corrected DLCO <50% are
             not eligible.

          -  Patients with cardiac disease such as recent myocardial infarction (< 3 months prior),
             unstable angina, or heart failure requiring medical intervention will undergo cardiac
             evaluation. Cardiac testing may include ECG, MUGA or echocardiogram, and/or thallium
             stress test as indicated to evaluate cardiac risks. Those patients with
             exercise-induced ischemia or an ejection fraction by MUGA or echocardiogram < 40% are
             not eligible.

          -  Due to the origin of the KLH protein, patients with a history of seafood allergy are
             excluded from receiving KLH.

          -  Hypersensitivity to any component of the vaccine, including Thimerosal, a mercury
             derivative, is a contraindication (taken from tetanus toxoid package insert).

          -  The occurrence of any type of neurologic symptoms to tetanus vaccine in the past is a
             contraindication to further use (taken from tetanus toxoid package insert).

          -  Subjects who have had tetanus toxoid within the last 7 years will not receive the
             tetanus vaccine component of this

          -  Pregnant (positive pregnancy test) or lactating women. Use of LMI vaccine during
             pregnancy is not approved for use by the FDA during pregnancy. IL-2 is pregnancy
             category C - risk in pregnancy cannot be ruled out.