Clinical Trial of a Therapeutic Vaccine With NY-ESO-1 in Combination With the Adjuvant Monophosphoryl Lipid A (MPLA)
Conditions
Cancer. - Melanoma. - Ovarian Cancer. - Lung Cancer.
Conditions: official terms
Ovarian Neoplasms
Conditions: Keywords
Cancer., Melanoma., Ovarian cancer., Lung cancer., NY-ESO-1., MPLA (monophosphoryl lipid A)., Tumor antigen., Bordetella pertussis.
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: NY-ESO-1 combined with MPLA Type: Biological
Name: NY-ESO-1 combined with MPLA vaccine Type: Biological
Overall Status
Not yet recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 60 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
Location
Hospital das Clinicas da FMUSP
São Paulo, Brazil
Status: Not yet recruiting
Start Date
July 2012
Completion Date
July 2013
Sponsors
Instituto de Investigação em Imunologia
Source
Instituto de Investigação em Imunologia
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page