2017-05-01
2020-02-28
2020-12-31
30
NCT03165591
Immunitor LLC
Immunitor LLC
INTERVENTIONAL
Open Label Immunotherapy Trial of Inoperable Pancreatic Cancer
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2017-05-18 | N/A | 2019-08-29 |
2017-05-23 | N/A | 2019-08-30 |
2017-05-24 | N/A | 2019-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Experimental Daily tablet of V3-P given orally for 2 months | BIOLOGICAL: V3-P
|
| Primary Outcome Measures | 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 |
| Secondary Outcome Measures | 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 | Monthly evaluation of fasting glucose and bilirubin levels as a surrogate for pancreatic function | 3 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: aldar Bourinbaiar, MD/PhD, PhD Phone Number: +976-95130306 Email: immunitor@gmail.com |
Study Contact Backup Name: Marina Tarakanovskaya, MD Phone Number: +976-95130306 Email: marinatarakanovskaya@yahoo.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
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