Dendritic Cells (DC) Vaccine for Metastatic Melanoma
Condition: Metastatic Melanoma
MeSH terms: Melanoma
Intervention: Vaccination
Intervention description: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Melanoma

Summary:

      The purpose of this study is to determine what effect using an experimental tumor vaccine (a
      substance or group of substances meant to cause the immune system to respond to a tumor) made
      using patients' own tumor cells and blood cells will have on their melanoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have Stage III-IV melanoma (any tumor thickness and any number of lymph
             node involvement, and in-transit metastases, or distant metastases) (AJCC). Each
             diagnosis will be confirmed by pathology review at the Melanoma Center of the
             University of Pittsburgh Cancer Institute.

          -  All subjects have to be HLA-A2 positive (required for immunologic testing).

          -  Subjects must have recovered fully from surgery.

          -  Availability of resectable or tissue banked tumor cells for autologous tumor dendritic
             cell vaccine preparation.

          -  Sufficient number of tumor cells available for autologous tumor dendritic cell vaccine
             preparation (min 2.6 x 10 7).

          -  Sufficient number of DCs of at least 12 X 10 6 for preparation of the autologous tumor
             dendritic cell vaccine preparation (if less than needed number of cells will be
             obtained by one course of leukopheresis, the second leukopheresis will be repeated 2
             weeks apart).

          -  Subjects must not have received any chemotherapy or immunotherapy within the four
             weeks preceding vaccination (six weeks for nitrosourea, mitomycin).

          -  Subjects must have an expected survival of greater than or equal to 12 months.

          -  Subjects must have an ECOG performance status 0 or 1.

          -  Subjects must have the following initial and subsequent pretreatment

          -  laboratory parameters: Granulocytes >=2,500/mm3 Lymphocytes >=1000/mm3 Platelets
             >100,000/mm3 Serum Creatinine <=1.5 X the ULN AST, ALT, GGT, LDH, Alk phos <= 2.5 X
             the ULN Serum Bilirubin <=1.5 X ULN

          -  Subjects must be >= 18 years of age and must be able to understand the written
             informed consent.

          -  No evidence of active infection, regardless of the degree of severity or localization.
             Subjects with active infections (whether or not they require antibiotic therapy) may
             be eligible after complete resolution of the infection. Subjects on antibiotic therapy
             must be off antibiotics for at least 7 days before beginning treatment.

          -  Subjects with measurable disease must have an evaluation for extent of disease (tumor
             staging) performed within 30 days of start of treatment.

          -  Pretreatment baseline evaluations for laboratory parameters must be obtained within 10
             to18 days of subject registration

        Exclusion Criteria:

          -  Subjects currently treated with anti inflammatory agents including glucocorticoid
             therapy are ineligible.

          -  Subjects currently on treatment with steroids are ineligible, but may receive the DC
             autologous tumor dendritic cell vaccine 4 weeks after steroid cessation. Subjects on
             maintenance steroids because of adrenal insufficiency are eligible.

          -  Subjects with severely abnormal liver function tests [AST (SGOT), ALT (SGPT), GGT,
             Alk.Phos, LDH, and total bilirubin greater than 2 X ULN].

          -  Subjects with uncontrolled pain.

          -  Subjects with autoimmune disease, HIV, and hepatitis

          -  Subjects with symptomatic brain metastasis.

          -  Subjects with active prior malignancy (with exception of non-melanoma skin cancers and
             carcinoma in situ of the cervix).

          -  Subjects who have been previously immunized with melanoma vaccine until 10 subjects
             have been registered in each treatment arm.

          -  Subjects who are pregnant.

          -  Subjects who have sensitivity to drugs to provide local anesthesia.