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

NCT01584115 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2012-04-25

No results posted yet for this study

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.

Conditions

  • Cancer.
  • Melanoma.
  • Ovarian Cancer.
  • Lung Cancer.

Interventions

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

Sponsors & Collaborators

  • Butantan Institute

    collaborator OTHER_GOV

  • Instituto de Investigação em Imunologia

    lead OTHER

Principal Investigators

  • Pedro Giavina-Bianchi, MD,PhD · University of Sao Paulo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01584115 on ClinicalTrials.gov