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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01082198
First received: March 5, 2010
Last updated: September 30, 2010
Last verified: March 2010
History of Changes
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Adjuvant Vaccination With Melanoma Antigen Pulsed Dendritic Cells (DCs) in Stage III Melanoma Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Immune response [ Designated as safety issue: No ]
  • Disease-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: Yes ]

Estimated Enrollment: 22
Study Start Date: October 2002
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01082198

Locations
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 Memorial Cancer Center, Institute of Oncology
Investigators
Principal Investigator: Sergiusz Markowicz, MD Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01082198     History of Changes
Other Study ID Numbers: CDR0000666511, MSCMI-21/01/02, EU-21006
Study First Received: March 5, 2010
Last Updated: September 30, 2010
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage III melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
 Nevi and Melanomas
Adjuvants, Immunologic
Keyhole-limpet hemocyanin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013