Open Label Immunotherapy Trial of Inoperable Pancreatic Cancer

Pancreatic Cancer Non-resectable Clinical Trial

— V3-P  

Official title:

Open Label Phase II Immunotherapy Trial of Inoperable Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03165591
• Other study ID #: Panc-001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 1, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2019
• Source: Immunitor LLC
• Contact: aldar Bourinbaiar, MD/PhD, PhD
• Phone: +976-95130306
• Email: immunitor[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosis of inoperable pancreatic cancer

• higher than normal of serum CA19.9 tumor marker levels (40 IU/ml)

• must be able to swallow tablets

Exclusion Criteria:

• negative for CA19.9

• pregnant, breast feeding women

• unwillingness to provide written consent

Related Conditions & MeSH terms

• Pancreatic Cancer Non-resectable
• Pancreatic Neoplasms

Intervention

Biological:
• V3-P
one tablet of V3-P given once daily for 2 months

Locations

Country	Name	City	State
Mongolia	Immunitor LLC	Ulaanbaatar
Mongolia	National Cancer Center	Ulaanbaatar

Sponsors (1)

Lead Sponsor	Collaborator
Immunitor LLC

Country where clinical trial is conducted

Mongolia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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