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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2012 by Pedro Giavina-Bianchi, Instituto de Investigação em Imunologia.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01584115
First Posted: April 24, 2012
Last Update Posted: April 25, 2012
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.
Collaborator:
Butantan Institute
Information provided by (Responsible Party):
Pedro Giavina-Bianchi, Instituto de Investigação em Imunologia
  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: Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Pedro Giavina-Bianchi, Instituto de Investigação em Imunologia:

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


Secondary Outcome Measures:
  • 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).


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Other Grant/Funding Number: CNPq 577582/2008-9 )
First Submitted: April 21, 2012
First Posted: April 24, 2012
Last Update Posted: April 25, 2012
Last Verified: April 2012

Keywords provided by Pedro Giavina-Bianchi, 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:
Ovarian Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Melanoma
Nevi and Melanomas
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Vaccines
Monophosphoryl lipid A
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic