Melanoma Vaccine in Treating Patients With Stage III Melanoma After Surgery to Remove Lymph Nodes
Primary Purpose
Melanoma (Skin)
Status
Unknown status
Phase
Phase 1
Locations
Poland
Study Type
Interventional
Intervention
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
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage III melanoma
Eligibility 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
Sites / Locations
- Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - WarsawRecruiting
Outcomes
Primary Outcome Measures
Immune response
Disease-free survival
Overall survival
Adverse events
Secondary Outcome Measures
Full Information
NCT ID
NCT01082198
First Posted
March 5, 2010
Last Updated
August 23, 2013
Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
1. Study Identification
Unique Protocol Identification Number
NCT01082198
Brief Title
Melanoma Vaccine in Treating Patients With Stage III Melanoma After Surgery to Remove Lymph Nodes
Official Title
Adjuvant Vaccination With Melanoma Antigen Pulsed Dendritic Cells (DCs) in Stage III Melanoma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2002 (undefined)
Primary Completion Date
April 2010 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
stage III melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Masking
None (Open Label)
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
HLA-A1-binding MAGE-1/MAGE-3 multipeptide-pulsed autologous dendritic cell vaccine
Intervention Type
Biological
Intervention Name(s)
HLA-A2-binding TYR/MART-1/gp100 multipeptide-pulsed autologous dendritic cell vaccine
Intervention Type
Biological
Intervention Name(s)
autologous melanoma lysate-pulsed autologous dendritic cell vaccine
Intervention Type
Biological
Intervention Name(s)
autologous melanoma lysate/KLH-pulsed autologous dendritic cell vaccine
Intervention Type
Biological
Intervention Name(s)
dendritic cell-idiotype-keyhole limpet hemocyanin vaccine
Intervention Type
Other
Intervention Name(s)
flow cytometry
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Primary Outcome Measure Information:
Title
Immune response
Title
Disease-free survival
Title
Overall survival
Title
Adverse events
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergiusz Markowicz, MD
Organizational Affiliation
Maria Sklodowska-Curie National Research Institute of Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
48-22-546-2660
12. IPD Sharing Statement
Learn more about this trial
Melanoma Vaccine in Treating Patients With Stage III Melanoma After Surgery to Remove Lymph Nodes
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