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

This study is not yet open for participant recruitment.
Verified April 2012 by Instituto de Investigação em Imunologia
Sponsor:
Collaborator:
Butantan Institute
Information provided by (Responsible Party):
Pedro Giavina-Bianchi, Instituto de Investigação em Imunologia
ClinicalTrials.gov Identifier:
NCT01584115
First received: April 21, 2012
Last updated: April 24, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Cancer.
Melanoma.
Ovarian Cancer.
Lung Cancer.
 Biological: NY-ESO-1 combined with MPLA
Biological: NY-ESO-1 combined with MPLA vaccine
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Instituto de Investigação em Imunologia:

Primary Outcome Measures:
  • Safety [ Time Frame: Six months after immunization. ] [ Designated as safety issue: Yes ]
    CTCAE (Common Terminology Criteria for Adverse Events)


Secondary Outcome Measures:
  • Immunogenicity [ Time Frame: Six months after immunization. ] [ Designated as safety issue: No ]
    IgG against NY-ESO-1 (ELISA). NY-ESO-1-specific T cells CD4+ and CD8+ (ELISPOT and FACs - flow citometry with tetramers).


Estimated Enrollment: 15
Study Start Date: July 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NY-ESO-1
NY-ESO-1 combined with MPLA vaccine
 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01584115

Contacts
Contact: Pedro Giavina-Bianchi, PhD,MD (5511) 26616098 pbianchi@usp.br
Contact: Marcelo V Aun, MD (5511) 26616225 marcelovivoloaun@yahoo.com.br

Locations
Brazil
Hospital das Clinicas da FMUSP Not yet recruiting
São Paulo, Brazil
Sponsors and Collaborators
Instituto de Investigação em Imunologia
Butantan Institute
Investigators
Principal Investigator: Pedro Giavina-Bianchi, MD,PhD University of São Paulo
  More Information

No publications provided

Responsible Party: Pedro Giavina-Bianchi, Principal Investigator, Instituto de Investigação em Imunologia
ClinicalTrials.gov Identifier: NCT01584115     History of Changes
Other Study ID Numbers: 6889, CNPq 577582/2008-9
Study First Received: April 21, 2012
Last Updated: April 24, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Instituto de Investigação em Imunologia:
Cancer.
Melanoma.
Ovarian cancer.
Lung cancer.
 NY-ESO-1.
MPLA (monophosphoryl lipid A).
Tumor antigen.
Bordetella pertussis.

Additional relevant MeSH terms:
Lung Neoplasms
Melanoma
Ovarian Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
 Nevi and Melanomas
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Monophosphoryl lipid A
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013