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Trial record 5 of 139 for:    NY-ESO-1

Clinical Trial of a Therapeutic Vaccine With NY-ESO-1 in Combination With the Adjuvant Monophosphoryl Lipid A (MPLA)

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: NCT01584115
Recruitment Status : Unknown
Verified April 2012 by Pedro Giavina-Bianchi, Instituto de Investigação em Imunologia.
Recruitment status was:  Not yet recruiting
First Posted : April 24, 2012
Last Update Posted : April 25, 2012
Sponsor:
Collaborator:
Butantan Institute
Information provided by (Responsible Party):
Pedro Giavina-Bianchi, Instituto de Investigação em Imunologia

Tracking Information
First Submitted Date  ICMJE April 21, 2012
First Posted Date  ICMJE April 24, 2012
Last Update Posted Date April 25, 2012
Study Start Date  ICMJE July 2012
Estimated Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2012)
Safety [ Time Frame: Six months after immunization. ]
CTCAE (Common Terminology Criteria for Adverse Events)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2012)
Immunogenicity [ Time Frame: Six months after immunization. ]
IgG against NY-ESO-1 (ELISA). NY-ESO-1-specific T cells CD4+ and CD8+ (ELISPOT and FACs - flow citometry with tetramers).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of a Therapeutic Vaccine With NY-ESO-1 in Combination With the Adjuvant Monophosphoryl Lipid A (MPLA)
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer.
  • Melanoma.
  • Ovarian Cancer.
  • Lung Cancer.
Intervention  ICMJE
  • Biological: NY-ESO-1 combined with MPLA
    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).
  • Biological: NY-ESO-1 combined with MPLA vaccine
    Immunization os cancer patients with NY-ESO-1 combined with MPLA vaccine
Study Arms  ICMJE Experimental: NY-ESO-1
NY-ESO-1 combined with MPLA vaccine
Interventions:
  • Biological: NY-ESO-1 combined with MPLA
  • Biological: NY-ESO-1 combined with MPLA vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 23, 2012)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2013
Estimated Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01584115
Other Study ID Numbers  ICMJE 6889
CNPq 577582/2008-9 ( Other Grant/Funding Number: CNPq 577582/2008-9 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pedro Giavina-Bianchi, Instituto de Investigação em Imunologia
Study Sponsor  ICMJE Instituto de Investigação em Imunologia
Collaborators  ICMJE Butantan Institute
Investigators  ICMJE
Principal Investigator: Pedro Giavina-Bianchi, MD,PhD University of São Paulo
PRS Account Instituto de Investigação em Imunologia
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP