Vaccine Therapy Using Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Treating Patients With Metastatic Melanoma
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Intervention: incomplete Freund's adjuvant; melanoma helper peptide vaccine; multi-epitope melanoma peptide vaccine; sargramostim; tetanus peptide melanoma vaccine
Intervention description: Given by injection; Given by injection; Given by injection; Given by injection; Given by injection
Intervention MeSH terms: Molgramostim; Vaccines; Sargramostim; Freund's Adjuvant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 175.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage IV melanoma; recurrent melanoma

Summary:

      RATIONALE: Vaccines made from peptides may make the body build an immune response to kill
      tumor cells.

      PURPOSE: This randomized phase II trial is studying four different vaccines using melanoma
      peptides from cytotoxic T cells and helper T cells to see how well they work in treating
      patients with metastatic melanoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed stage IV melanoma

               -  Multiple primary melanomas allowed

               -  Metastasis may be from a cutaneous, mucosal, ocular, or unknown primary site

          -  Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST criteria)

          -  Must have 2 extremities uninvolved with tumor

          -  Must have at least 2 intact (undissected) axillary and/or inguinal lymph node basins

               -  Prior sentinel node biopsy may not have violated the integrity of a nodal basin

                    -  This extremity may still be considered for vaccination

          -  Human Lymphocyte Antigen (HLA)-A1, -A2, or -A3 positive

          -  Prior brain metastases allowed provided all of the following are true:

               -  Surgically resected or treated with gamma-knife or stereotactic radiosurgery

               -  No disease progression in the brain for the past 3 months

               -  More than 30 days since prior steroids for the management of brain metastases

          -  Age: 18 and over

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

          -  Adequate organ function measured within 4 weeks before randomization:

               -  White blood cell (WBC) at least 4,000/mm^3

               -  Platelet count at least 100,000/mm^3

               -  Lymphocyte count at least 700/mm^3

               -  Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic
                  transaminase (SGPT) no greater than 2 times upper limit of normal (ULN)

               -  Bilirubin no greater than 2 times ULN

               -  Alkaline phosphatase no greater than 2 times ULN

               -  Lactic dehydrogenase no greater than 2 times ULN

               -  Creatinine no greater than 1.8 mg/dL

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No other malignancy within the past 5 years except nonmetastatic squamous cell or
             basal cell skin cancer, ductal or lobular carcinoma in situ of the breast, or
             carcinoma in situ of the cervix

          -  At least 4 weeks since prior sargramostim (GM-CSF), interferon alfa-2b, or
             interleukin-2

          -  More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

          -  More than 30 days since prior systemic corticosteroids, including any of the
             following:

               -  Therapeutic doses of oral steroids (e.g., prednisone or dexamethasone)

               -  Steroid inhalers (e.g., Advair)

                    -  Topical steroids and nasal steroids with low systemic absorption (e.g.,
                       fluticasone) or steroids with low systemic absorption (e.g., triamcinolone
                       hexacetonide) injected into a joint space allowed

          -  At least 4 weeks since prior local control or palliative radiotherapy and recovered

          -  Recovered from prior major surgery

        Exclusion criteria:

          -  More than 3 brain metastases

          -  Metastatic lesions greater than 2 cm

          -  Concurrent radiotherapy

          -  Prior radiotherapy to measurable disease

          -  Concurrent surgery

          -  Concurrent corticosteroids

          -  Concurrent topical or systemic steroids

          -  Concurrent chemotherapy

          -  Prior vaccination with any of the study peptides

          -  Recent (within the past year) or concurrent addiction to alcohol or illicit drugs

          -  Pregnant or nursing

          -  Known or suspected major allergy to any components of the study vaccine

          -  Significant detectable infection

          -  Immunosuppression conditions

          -  Prior or active autoimmune disorder requiring cytotoxic or mmunosuppressive therapy,
             except for any of the following:

               -  Presence of laboratory evidence of autoimmune disease (e.g., positive antinuclear
                  antibody (ANA) titer) without symptoms

               -  Clinical evidence of vitiligo or other forms of depigmenting illness

               -  Mild arthritis requiring nonsteroidal anti-inflammatory medication

          -  Autoimmune disorder with visceral involvement