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| ID | Type | Description | Link |
|---|---|---|---|
| CNPq 577582/2008-9 | Other Grant/Funding Number | CNPq 577582/2008-9 |
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| Name | Class |
|---|---|
| Butantan Institute | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NY-ESO-1 | Experimental | NY-ESO-1 combined with MPLA vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | CTCAE (Common Terminology Criteria for Adverse Events) | Six months after immunization. |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity | IgG against NY-ESO-1 (ELISA). NY-ESO-1-specific T cells CD4+ and CD8+ (ELISPOT and FACs - flow citometry with tetramers). | Six months after immunization. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pedro Giavina-Bianchi, PhD,MD | Contact | (5511) 26616098 | pbianchi@usp.br | |
| Marcelo V Aun, MD | Contact | (5511) 26616225 | marcelovivoloaun@yahoo.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Pedro Giavina-Bianchi, MD,PhD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das Clinicas da FMUSP | São Paulo | Brazil |
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| NY-ESO-1 combined with MPLA vaccine | Biological | Immunization os cancer patients with NY-ESO-1 combined with MPLA vaccine |
|
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D008545 | Melanoma |
| D010051 | Ovarian Neoplasms |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C048436 | monophosphoryl lipid A |
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