Phase I Clinical Trial of a Therapeutic Vaccine for Malignancies, Comprising the Tumor Antigen NY-ESO-1 in Combination With the Adjuvant MPLA of Bordetella Pertussis. Evaluation of Toxicity and Immunogenicity
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Cancer.
- Sponsor
- Instituto de Investigação em Imunologia
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Safety
- Last Updated
- 14 years ago
Overview
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.
Investigators
Pedro Giavina-Bianchi
Principal Investigator
Instituto de Investigação em Imunologia
Eligibility 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.
Outcomes
Primary Outcomes
Safety
Time Frame: Six months after immunization.
CTCAE (Common Terminology Criteria for Adverse Events)
Secondary Outcomes
- Immunogenicity(Six months after immunization.)