Melanoma Vaccine in Treating Patients With Stage III Melanoma After Surgery to Remove Lymph Nodes
NCT ID: NCT01082198
Last Updated: 2013-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
22 participants
INTERVENTIONAL
2002-10-31
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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HLA-A1-binding MAGE-1/MAGE-3 multipeptide-pulsed autologous dendritic cell vaccine
HLA-A2-binding TYR/MART-1/gp100 multipeptide-pulsed autologous dendritic cell vaccine
autologous melanoma lysate-pulsed autologous dendritic cell vaccine
autologous melanoma lysate/KLH-pulsed autologous dendritic cell vaccine
dendritic cell-idiotype-keyhole limpet hemocyanin vaccine
flow cytometry
adjuvant therapy
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Maria Sklodowska-Curie National Research Institute of Oncology
OTHER
Principal Investigators
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Sergiusz Markowicz, MD
Role: PRINCIPAL_INVESTIGATOR
Maria Sklodowska-Curie National Research Institute of Oncology
Locations
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Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
Warsaw, , Poland
Countries
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Facility Contacts
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Contact Person
Role: primary
Other Identifiers
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MSCMI-21/01/02
Identifier Type: -
Identifier Source: secondary_id
EU-21006
Identifier Type: -
Identifier Source: secondary_id
CDR0000666511
Identifier Type: -
Identifier Source: org_study_id