Melanoma Vaccine in Treating Patients With Stage III Melanoma After Surgery to Remove Lymph Nodes

Maria Sklodowska-Curie National Research Institute of Oncology

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Melanoma (Skin)

Treatments: Biological: dendritic cell-idiotype-keyhole limpet hemocyanin vaccine; Biological: HLA-A2-binding TYR/MART-1/gp100 multipeptide-pulsed autologous dendritic cell vaccine; Biological: autologous melanoma lysate/KLH-pulsed autologous dendritic cell vaccine; Biological: HLA-A1-binding MAGE-1/MAGE-3 multipeptide-pulsed autologous dendritic cell vaccine; Procedure: adjuvant therapy; Biological: autologous melanoma lysate-pulsed autologous dendritic cell vaccine; Other: flow cytometry

Study type: Interventional

Funder types: Other

Identifiers

NCT01082198

EU-21006

CDR0000666511

MSCMI-21/01/02

Details and patient eligibility

About

RATIONALE: Vaccines made from dendritic cells and tumor antigen peptides or a person's tumor cells may help the body build an effective immune response to kill tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best way to give melanoma vaccine in treating patients with stage III melanoma after surgery to remove the lymph nodes.

Full description

OBJECTIVES:

• Determine the feasibility of adjuvant melanoma vaccine comprising autologous dendritic cells pulsed with tumor antigen peptides in patients with stage III melanoma following lymphadenectomy.
• Determine the immune response (skin test of delayed-type hypersensitivity and flow cytometric enumeration of peripheral blood CD8+ lymphocytes producing IFN-γ) to this regimen in these patients.
• Determine clinical outcome (disease-free survival, overall survival, and adverse events) in patients treated with this regimen.

OUTLINE: Patients undergo leukapheresis for collection of peripheral blood mononuclear cells (PBMCs) and bone marrow mononuclear cells. Autologous dendritic cells (DCs) prepared from PBMCs and bone marrow mononuclear cells are exposed to various antigens and peptides, and autologous tumor cell lysate, if available. Patients receive autologous DCs pulsed with melanoma-associated antigen peptides, and autologous DCs pulsed with tumor lysates (if available), subcutaneously in weeks 0, 2, 5, 8, 12, 16, 20, 26, 31, 50, and 102. Patients with no evidence of disease may receive another booster injection 5 years after the start of vaccination.

Blood samples are examined via flow cytometry and skin testing is performed to evaluate immune response.

Enrollment: 22 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Diagnosis of stage III melanoma

  • Has undergone therapeutic lymphadenectomy
  • More than 1 lymph node involvement or extracapsular extension of metastatic melanoma cells (stage N1b-N3 disease according to AJCC 2002)

• HLA type A1 and/or A2 or A3 (if autologous tumor lysate is available)

• No presence of distant metastases

PATIENT CHARACTERISTICS:

• No other malignancy
• No evidence of lung, heart, liver, or renal failure or severe neurologic disorder
• No autoimmune disease or atopic allergy
• No HIV infection or presence of anti-HIV antibodies
• No presence of hepatitis B surface antigen or antibodies against hepatitis C virus

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics