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Open Label Immunotherapy Trial of Inoperable Pancreatic Cancer (V3-P)

Primary Purpose

Pancreatic Cancer Non-resectable

Status

Unknown status

Phase

Phase 1

Locations

Mongolia

Study Type

Interventional

Intervention

V3-P

About this trial

This is an interventional treatment trial for Pancreatic Cancer Non-resectable

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Immunitor LLCRecruiting
National Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

Daily tablet of V3-P given orally for 2 months

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Effect of V3-P on sugar and bilirubin levels

Monthly evaluation of fasting glucose and bilirubin levels as a surrogate for pancreatic function

Full Information

NCT ID

NCT03165591

First Posted

May 18, 2017

Last Updated

August 29, 2019

Sponsor

Immunitor LLC

1. Study Identification

Unique Protocol Identification Number

NCT03165591

Brief Title

Open Label Immunotherapy Trial of Inoperable Pancreatic Cancer

Acronym

V3-P

Official Title

Open Label Phase II Immunotherapy Trial of Inoperable Pancreatic Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Unknown status

Study Start Date

May 1, 2017 (Actual)

Primary Completion Date

February 28, 2020 (Anticipated)

Study Completion Date

December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Immunitor LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer Non-resectable

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Arm Description

Daily tablet of V3-P given orally for 2 months

Intervention Type

Biological

Intervention Name(s)

V3-P

Other Intervention Name(s)

oral tableted therapeutic vaccine

Intervention Description

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

Primary Outcome Measure Information:

Title

Effect of V3-P on tumor burden

Description

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.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Safety of V3-P

Description

Toxicity or adverse side effects, such as diarrhea and vomiting, will be graded according to accepted standards, e.g., NCI CTEP CTCAE.

Time Frame

3 months

Title

Effect of V3-P on sugar and bilirubin levels

Description

Monthly evaluation of fasting glucose and bilirubin levels as a surrogate for pancreatic function

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

aldar Bourinbaiar, MD/PhD, PhD

Phone

+976-95130306

immunitor@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Marina Tarakanovskaya, MD

Phone

+976-95130306

marinatarakanovskaya@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Allen Bain, PhD

Organizational Affiliation

Immunitor Inc.

Official's Role

Study Chair

Facility Information:

Facility Name

Immunitor LLC

City

Ulaanbaatar

Country

Mongolia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aldar Bourinbaiar, MD

Phone

97695130306

aldar@immunitor.com

First Name & Middle Initial & Last Name & Degree

Marina Tarakanovskaya, MD

marinatarakanovskaya@yahoo.com

First Name & Middle Initial & Last Name & Degree

Chinburen Jigjidsuren, MD

Facility Name

National Cancer Center

City

Ulaanbaatar

Country

Mongolia

Individual Site Status

Enrolling by invitation

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

The data will be shared with other researchers upon request on study conclusion

Citations:

PubMed Identifier

28443252

Citation

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.

Results Reference

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Open Label Immunotherapy Trial of Inoperable Pancreatic Cancer

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