Clinical trial NCT01082198: Melanoma Vaccine in Treating Patients With Stage III Melanoma After Surgery to Remove Lymph Nodes
Official title: Adjuvant Vaccination With Melanoma Antigen Pulsed Dendritic Cells (DCs) in Stage III Melanoma Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Melanoma (Skin)
Keywords: stage III melanoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2010-03-08
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Immune response
measure: Disease-free survival
measure: Overall survival
measure: Adverse events
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
Study officials:
affiliation: Maria Sklodowska-Curie National Research Institute of Oncology
name: Sergiusz Markowicz, MD
role: PRINCIPAL_INVESTIGATOR
References: