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| ID | Type | Description | Link |
|---|---|---|---|
| MSCMI-21/01/02 | |||
| EU-21006 |
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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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 | Biological | |||
| flow cytometry | Other | |||
| adjuvant therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Immune response | ||
| Disease-free survival | ||
| Overall survival | ||
| Adverse events |
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DISEASE CHARACTERISTICS:
Diagnosis of stage III melanoma
HLA type A1 and/or A2 or A3 (if autologous tumor lysate is available)
No presence of distant metastases
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Sergiusz Markowicz, MD | Maria Sklodowska-Curie National Research Institute of Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw | Recruiting | Warsaw | 02-781 | Poland |
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| Procedure |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D005434 | Flow Cytometry |
| D017024 | Chemotherapy, Adjuvant |
| ID | Term |
|---|---|
| D002469 | Cell Separation |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003592 | Cytophotometry |
| D005470 | Fluorometry |
| D008163 | Luminescent Measurements |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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