Safety And Efficacy Of The Therapeutic Vaccine GI-4000 In Combination With Gemcitabine Versus Placebo For The Treatment Of Non-metastatic, Post-resection Pancreas Cancer

Study Overview

Safety and Efficacy of the Therapeutic Vaccine GI-4000 in Combination With Gemcitabine Versus Placebo for the Treatment of Non-metastatic, Post-resection Pancreas Cancer

The GI-4000 therapeutic vaccine or placebo will be injected under the skin of post-resection, non-metastatic pancreas cancer patients. Patients will be monitored for recurrence as well as safety, and immune responses related to the injections.

N/A

Pancreas Cancer

BIOLOGICAL: GI-4000
DRUG: Gemcitabine

GI-4000-02

Study Record Dates

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
First Submitted 2006-03-08	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2015-04-02
First Submitted that Met QC Criteria 2006-03-08	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2015-04-06
First Posted (ESTIMATED) 2006-03-10	Results First Posted N/A	Last Verified 2015-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Single Group

Masking:
Triple

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: 1 Gencitabine	BIOLOGICAL: GI-4000 Heat-killed yeast cell transfected with target ras mutation.
EXPERIMENTAL: 2 Gemcitabine with GI-4000	DRUG: Gemcitabine Chemotherapy

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: 1

Gencitabine

BIOLOGICAL: GI-4000

Heat-killed yeast cell transfected with target ras mutation.

EXPERIMENTAL: 2

Gemcitabine with GI-4000

DRUG: Gemcitabine

Chemotherapy

Primary Outcome Measures	Measure Description	Time Frame
Recurrence free time and survival		5 years

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

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:

Patients with non-metastatic pancreas cancer post-resection that have a product-related ras mutation
>18 years of age
Negative skin test for hypersensitivity to Saccharomyces cerevisiae

Metastatic pancreas cancer patients post-resection
Patients with no product-related ras mutation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Muscarella P, Bekaii-Saab T, McIntyre K, Rosemurgy A, Ross SB, Richards DA, Fisher WE, Flynn PJ, Mattson A, Coeshott C, Roder H, Roder J, Harrell FE, Cohn A, Rodell TC, Apelian D. A Phase 2 Randomized Placebo-Controlled Adjuvant Trial of GI-4000, a Recombinant Yeast Expressing Mutated RAS Proteins in Patients with Resected Pancreas Cancer. J Pancreat Cancer. 2021 Mar 23;7(1):8-19. doi: 10.1089/pancan.2020.0021. eCollection 2021.

Learn

Resources

PatientS

Caregivers

Clinical Trial Record