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

Instituto de Investigação em Imunologia

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Lung Cancer.

Cancer.

Ovarian Cancer.

Melanoma.

Treatments

Biological: NY-ESO-1 combined with MPLA vaccine

Biological: NY-ESO-1 combined with MPLA

Study type

Interventional

Funder types

Other

Identifiers

NCT01584115

6889

CNPq 577582/2008-9 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.