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

Phase 1

• Conditions: Cancer.; Melanoma.; Ovarian Cancer.; Lung Cancer.
• Interventions: Biological: NY-ESO-1 combined with MPLA; Biological: NY-ESO-1 combined with MPLA vaccine

• Registration Number: NCT01584115
• Lead Sponsor: Instituto de Investigação em Imunologia

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.

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.

Study Timeline

• Status Verified: 2012-04
• Study First Submitted: 2012-04-21
• Study First Submitted QC: 2012-04-23
• Study First Posted: 2012-04-24
• Last Update Submitted: 2012-04-24
• Last Update Posted: 2012-04-25
• Study Start: 2012-07
• Primary Completion: 2013-07
• Study Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NY-ESO-1	NY-ESO-1 combined with MPLA vaccine	NY-ESO-1 combined with MPLA vaccine
NY-ESO-1	NY-ESO-1 combined with MPLA	NY-ESO-1 combined with MPLA vaccine

Primary Outcome Measures

Name	Time	Method
Safety	Six months after immunization.	CTCAE (Common Terminology Criteria for Adverse Events)

Secondary Outcome Measures

Name	Time	Method
Immunogenicity	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).

Trial Locations

Locations (1)

Hospital das Clinicas da FMUSP; 🇧🇷 São Paulo, Brazil