Trial of Therapeutic Vaccine in Patients With Cholangiocarcinoma

NCT ID: NCT03042182

Last Updated: 2019-08-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-20
• Study Completion Date: 2020-04-20

Brief Summary

Cholangiocarcinoma (CCA) is a malignant neoplasm originating from the epithelial cells lining the intra- or extrahepatic biliary ducts. It is the second-most common liver cancer, after hepatocellular carcinoma (HCC). About 6,000 people in the United States develop bile duct cancer each year. One-year survival is less than 25% and no effective and safe systemic treatments are currently available. Last year the completion of open-label phase 2 trial (NCT02256514) of hepcortespenlisimut-L (V5) has been reported, which has shown that two-third of Mongolian patients with advanced HCC had a favorable clinical response, including complete remissions and with overall survival over 90% after 1 year. So far a few patients with CCA were treated with V5, but it appeared that their response rate was somewhat inferior to patients with HCC since two (both with hemochromatosis) out six patients died within 6 months. In one patient who had improved clinically, the improvement was correlated with decrease in CA19-9 tumor marker, but no marker profile information is available in regard to other CCA patients. As V5 tablets are made from pooled blood of patients with HCC, in theory, they will be not very useful to patients with CCA. The goal of this project is to manufacture an immunotherapeutic formulation made from pooled heat- and chemically-inactivated blood from donors with CCA and initiate pilot open-label trial in 20 cholangiocarcinoma patients. This clinical trial will be conducted in collaboration with the National Cancer Center.

Detailed Description

Upon obtaining regulatory and ethical approvals the Phase II single-arm study will be initiated at the NCC involving 20 patients with confirmed CCA diagnosis. The trial will be short, it will last only 2 months, but this will be sufficient to gauge the safety and efficacy. Only those patients who have higher than normal levels of CA19-9 tumor marker will be enrolled, which will serve as a surrogate marker in a manner alpha fetoprotein (AFP) has been used as a predictor of clinical response in HCC patients. Additional primary endpoints will be overall survival and changes in tumor burden, with secondary endpoints being liver function tests and changes in quality of life.

Conditions

Cholangiocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single pill of V3-X vaccine administered once daily

One pill of oral therapeutic vaccine V3-X administered to patients with cholangiocarcinoma for two months and changes in CA19.9 tumor marker from baseline levels versus post-treatment levels will be assessed as correlates of changes in tumor burden

Group Type: EXPERIMENTAL

Oral therapeutic vaccine V3-X to treat cholangiocarcinoma

Intervention Type: BIOLOGICAL

One single pill of V3-X vaccine administered once per day to patients with cholangiocarcinoma

Interventions

Oral therapeutic vaccine V3-X to treat cholangiocarcinoma

One single pill of V3-X vaccine administered once per day to patients with cholangiocarcinoma

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• only those positive for CA19.9

Exclusion Criteria

• pregnant and lactating females

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Immunitor LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

aldar bourinbaiar, MD/PhD

Role: STUDY_DIRECTOR

Immunitor LLC

Locations

Immunitor LLC

Ulaanbaatar, CA, Mongolia

Site Status: ENROLLING_BY_INVITATION

National Cancer Center

Ulaanbaatar, , Mongolia

Site Status: RECRUITING

Countries

Mongolia

Central Contacts

Galyna Kutsyna, MD, MD/PhD

Role: CONTACT

kutsynagalyna@yahoo.com

Aldar Bourinbayar, MD

Role: CONTACT

immunitor@gmail.com

+97695130306

Facility Contacts

batchuluun purev, md

Role: primary

munkhzaya chogsom, md

Role: backup

Other Identifiers

03

Identifier Type: -

Identifier Source: org_study_id