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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


Phase 1/Phase 2
18 Years
60 Years
Not Enrolling
Both
Cancer., Melanoma., Ovarian Cancer., Lung Cancer.

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety

Outcome Description:

CTCAE (Common Terminology Criteria for Adverse Events)

Outcome Time Frame:

Six months after immunization.

Safety Issue:

Yes

Principal Investigator

Pedro Giavina-Bianchi, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of São Paulo

Authority:

Brazil: National Health Surveillance Agency

Study ID:

6889

NCT ID:

NCT01584115

Start Date:

July 2012

Completion Date:

July 2013

Related Keywords:

  • Cancer.
  • Melanoma.
  • Ovarian Cancer.
  • Lung Cancer.
  • Cancer.
  • Melanoma.
  • Ovarian cancer.
  • Lung cancer.
  • NY-ESO-1.
  • MPLA (monophosphoryl lipid A).
  • Tumor antigen.
  • Bordetella pertussis.
  • Lung Neoplasms
  • Melanoma
  • Ovarian Neoplasms

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