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

NCT01584115 | Unknown Phase 1 DMC

• 2 other identifiers: 6889CNPq 577582/2008-9
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer.; Melanoma.; Ovarian Cancer.; Lung Cancer.

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Safety

  CTCAE (Common Terminology Criteria for Adverse Events)

  Six months after immunization.

Secondary Outcomes (1)

• Immunogenicity

  Six months after immunization.

Study Arms (1)

NY-ESO-1

EXPERIMENTAL

NY-ESO-1 combined with MPLA vaccine

Biological: NY-ESO-1 combined with MPLA; Biological: NY-ESO-1 combined with MPLA vaccine

Interventions

NY-ESO-1 combined with MPLA BIOLOGICAL

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).

NY-ESO-1

NY-ESO-1 combined with MPLA vaccine BIOLOGICAL

Immunization os cancer patients with NY-ESO-1 combined with MPLA vaccine

NY-ESO-1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Will be excluded from the study patients with continuous use of systemic steroids, immunosuppressive agents and antibiotics, and with severe chronic systemic disease.

Sponsors & Collaborators

• Instituto de Investigação em Imunologia: lead
• Butantan Institute: collaborator

Study Sites (1)

Hospital das Clinicas da FMUSP

São Paulo, Brazil

Location

MeSH Terms

Conditions

Neoplasms; Melanoma; Ovarian Neoplasms; Lung Neoplasms

Interventions

monophosphoryl lipid A

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Pedro Giavina-Bianchi, MD,PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro Giavina-Bianchi, PhD,MD

CONTACT

(5511) 26616098; pbianchi@usp.br

Marcelo V Aun, MD

CONTACT

(5511) 26616225; marcelovivoloaun@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 21, 2012
• First Posted: April 24, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: April 25, 2012

Record last verified: 2012-04

Locations

BR (1)