Melanoma Vaccine in Treating Patients With Stage III Melanoma After Surgery to Remove Lymph Nodes
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|ClinicalTrials.gov Identifier: NCT01082198|
Recruitment Status : Unknown
Verified March 2010 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : March 8, 2010
Last Update Posted : August 26, 2013
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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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Biological: HLA-A1-binding MAGE-1/MAGE-3 multipeptide-pulsed autologous dendritic cell vaccine Biological: HLA-A2-binding TYR/MART-1/gp100 multipeptide-pulsed autologous dendritic cell vaccine Biological: autologous melanoma lysate-pulsed autologous dendritic cell vaccine Biological: autologous melanoma lysate/KLH-pulsed autologous dendritic cell vaccine Biological: dendritic cell-idiotype-keyhole limpet hemocyanin vaccine Other: flow cytometry Procedure: adjuvant therapy||Phase 1 Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Masking:||None (Open Label)|
|Official Title:||Adjuvant Vaccination With Melanoma Antigen Pulsed Dendritic Cells (DCs) in Stage III Melanoma Patients|
|Study Start Date :||October 2002|
|Estimated Primary Completion Date :||April 2010|
- Immune response
- Disease-free survival
- Overall survival
- Adverse events
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01082198
|Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw||Recruiting|
|Warsaw, Poland, 02-781|
|Contact: Contact Person 48-22-546-2660|
|Principal Investigator:||Sergiusz Markowicz, MD||Maria Sklodowska-Curie National Research Institute of Oncology|
|Other Study ID Numbers:||
|First Posted:||March 8, 2010 Key Record Dates|
|Last Update Posted:||August 26, 2013|
|Last Verified:||March 2010|
stage III melanoma
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Physiological Effects of Drugs