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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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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.


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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma Vaccines

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Immune response
  2. Disease-free survival
  3. Overall survival
  4. Adverse events

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Poland
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw Recruiting
Warsaw, Poland, 02-781
Contact: Contact Person    48-22-546-2660      
Sponsors and Collaborators
Maria Sklodowska-Curie National Research Institute of Oncology
Investigators
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Principal Investigator: Sergiusz Markowicz, MD Maria Sklodowska-Curie National Research Institute of Oncology
More Information
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ClinicalTrials.gov Identifier: NCT01082198    
Other Study ID Numbers: CDR0000666511
MSCMI-21/01/02
EU-21006
First Posted: March 8, 2010    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: March 2010
Keywords provided by National Cancer Institute (NCI):
stage III melanoma
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
 Nevi and Melanomas
Vaccines
Keyhole-limpet hemocyanin
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic