Back to resultsClinical Trial of a Therapeutic Vaccine With NY-ESO-1 in Combination With the Adjuvant Monophosphoryl Lipid A (MPLA)
Primary Purpose
Cancer., Melanoma., Ovarian Cancer.
Status
Unknown status
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
NY-ESO-1 combined with MPLA
NY-ESO-1 combined with MPLA vaccine
Sponsored by
About this trial
This is an interventional treatment trial for Cancer. focused on measuring Cancer., Melanoma., Ovarian cancer., Lung cancer., NY-ESO-1., MPLA (monophosphoryl lipid A)., Tumor antigen., Bordetella pertussis.
Eligibility Criteria
Inclusion Criteria:
- In this study, will be included fifteen patients aged over 18 years, with a confirmed diagnosis of malignant neoplasms, which have proven NY-ESO-1 expression by immunohistochemistry and have undergone the standard treatment.
Exclusion Criteria:
- Will be excluded from the study patients with continuous use of systemic steroids, immunosuppressive agents and antibiotics, and with severe chronic systemic disease.
Sites / Locations
- Hospital das Clinicas da FMUSP
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NY-ESO-1
Arm Description
NY-ESO-1 combined with MPLA vaccine
Outcomes
Primary Outcome Measures
Safety
CTCAE (Common Terminology Criteria for Adverse Events)
Secondary Outcome Measures
Immunogenicity
IgG against NY-ESO-1 (ELISA). NY-ESO-1-specific T cells CD4+ and CD8+ (ELISPOT and FACs - flow citometry with tetramers).
Full Information
NCT ID
NCT01584115
First Posted
April 21, 2012
Last Updated
April 24, 2012
Sponsor
Instituto de Investigação em Imunologia
Collaborators
Butantan Institute
1. Study Identification
Unique Protocol Identification Number
NCT01584115
Brief Title
Clinical Trial of a Therapeutic Vaccine With NY-ESO-1 in Combination With the Adjuvant Monophosphoryl Lipid A (MPLA)
Official Title
Phase I Clinical Trial of a Therapeutic Vaccine for Malignancies, Comprising the Tumor Antigen NY-ESO-1 in Combination With the Adjuvant MPLA of Bordetella Pertussis. Evaluation of Toxicity and Immunogenicity
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
July 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto de Investigação em Imunologia
Collaborators
Butantan Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is a clinical trial phase I/II. Its goal is to determine the safety, tolerability, immunogenicity and efficacy of a therapeutic vaccine with the tumor antigen NY-ESO-1 combined with the adjuvant MPLA from B. pertussis in cancer patients.
Detailed Description
The safety and immunogenicity of the vaccine with the antigen NY-ESO-1 in combination with the MPLA will be evaluated in a phase 1 clinical trial conducted in patients with malignancies that express the antigen (lung, ovarian and melanoma). This study will involve 15 patients, who will receive 250 mcg of NY-ESO-1 and 100 mcg of MPLA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer., Melanoma., Ovarian Cancer., Lung Cancer.
Keywords
Cancer., Melanoma., Ovarian cancer., Lung cancer., NY-ESO-1., MPLA (monophosphoryl lipid A)., Tumor antigen., Bordetella pertussis.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NY-ESO-1
Arm Type
Experimental
Arm Description
NY-ESO-1 combined with MPLA vaccine
Intervention Type
Biological
Intervention Name(s)
NY-ESO-1 combined with MPLA
Intervention Description
Each patient will receive six doses of the formulation, administered intra-muscular, with an interval of 4 weeks between doses, and the first immunization performed 6 weeks after the completion of standard treatment. NY-ESO-1 (250 mcg) amd MPLA (100 mcg).
Intervention Type
Biological
Intervention Name(s)
NY-ESO-1 combined with MPLA vaccine
Intervention Description
Immunization os cancer patients with NY-ESO-1 combined with MPLA vaccine
Primary Outcome Measure Information:
Title
Safety
Description
CTCAE (Common Terminology Criteria for Adverse Events)
Time Frame
Six months after immunization.
Secondary Outcome Measure Information:
Title
Immunogenicity
Description
IgG against NY-ESO-1 (ELISA). NY-ESO-1-specific T cells CD4+ and CD8+ (ELISPOT and FACs - flow citometry with tetramers).
Time Frame
Six months after immunization.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
In this study, will be included fifteen patients aged over 18 years, with a confirmed diagnosis of malignant neoplasms, which have proven NY-ESO-1 expression by immunohistochemistry and have undergone the standard treatment.
Exclusion Criteria:
Will be excluded from the study patients with continuous use of systemic steroids, immunosuppressive agents and antibiotics, and with severe chronic systemic disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pedro Giavina-Bianchi, PhD,MD
Phone
(5511) 26616098
Email
pbianchi@usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Marcelo V Aun, MD
Phone
(5511) 26616225
Email
marcelovivoloaun@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Giavina-Bianchi, MD,PhD
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clinicas da FMUSP
City
São Paulo
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial of a Therapeutic Vaccine With NY-ESO-1 in Combination With the Adjuvant Monophosphoryl Lipid A (MPLA)
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