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Pancreatic cancer (PDA) is the most lethal form of cancer, and the fourth-leading cause of cancer-related death in the United States, with a survival rate of less than 7%.There are currently no treatments found to be effective for patients with advanced disease who are ineligible for surgery, a prognosis representing the majority of pancreatic cancer diagnoses. Pancreatic cancer is not amenable to chemotherapy as compared to other cancer types, leaving patients with practically no options except surgery.
We have made oral tableted therapeutic vaccine, V3-P, derived from pooled blood of patients with PDA in line with similar highly promising approach we have adopted for patients with hepatocellular carcinoma (HCC) and cholangiocarcinoma (CAA). Patients with PDA will be given one tablet per day of V3-P and followed up to see the outcome.
This study is an open label Phase II study aimed to recruit at least 20 patients with inoperable PDA and who are positive for CA19.9 pancreatic tumor marker. The presence of higher than normal levels of CA19.9 is the sole inclusion criteria. Patients will be given one tablet of V3-P daily and followed for three months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Daily tablet of V3-P given orally for 2 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V3-P | Biological | one tablet of V3-P given once daily for 2 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of V3-P on tumor burden | Changes in CA19.9 tumor marker induced by daily dose of oral vaccine V3-P in an open label trial in patients with inoperable pancreatic cancer. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of V3-P | Toxicity or adverse side effects, such as diarrhea and vomiting, will be graded according to accepted standards, e.g., NCI CTEP CTCAE. | 3 months |
| Effect of V3-P on sugar and bilirubin levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| aldar Bourinbaiar, MD/PhD, PhD | Contact | +976-95130306 | immunitor@gmail.com | |
| Marina Tarakanovskaya, MD | Contact | +976-95130306 | marinatarakanovskaya@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Allen Bain, PhD | Immunitor Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Immunitor LLC | Recruiting | Ulaanbaatar | Mongolia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28443252 | Background | Tarakanovskaya MG, Chinburen J, Batchuluun P, Munkhzaya C, Purevsuren G, Dandii D, Hulan T, Oyungerel D, Kutsyna GA, Reid AA, Borisova V, Bain AI, Jirathitikal V, Bourinbaiar AS. Open-label Phase II clinical trial in 75 patients with advanced hepatocellular carcinoma receiving daily dose of tableted liver cancer vaccine, hepcortespenlisimut-L. J Hepatocell Carcinoma. 2017 Apr 12;4:59-69. doi: 10.2147/JHC.S122507. eCollection 2017. |
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The data will be shared with other researchers upon request on study conclusion
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Monthly evaluation of fasting glucose and bilirubin levels as a surrogate for pancreatic function
| 3 months |
| National Cancer Center | Enrolling by invitation | Ulaanbaatar | Mongolia |