Back to resultsEffect of G17DT in Patients With Stage II/III Colorectal Cancer (CC5)
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
G17DT
Omeprazole
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects aged 18 to 70 years, inclusive
- Written informed consent was provided
- Histologically confirmed Stage II/III colorectal cancer after radical surgery
- A minimum of 3 months elapsed since completion of the chemotherapy for subjects who had received adjuvant chemotherapy
- Subject had recovered from any toxic effects of chemotherapy
Exclusion Criteria:
- Had a known local recurrence of colorectal cancer or presence of metastatic colorectal cancer lesions
- Was using an inadequate method of contraception (determined at the discretion of the investigator), only for women of childbearing potential who were sexually active
- Was unable to comply with the protocol
- Was unable to abstain from H2 receptor antagonists, PPIs or anticholinergics medications for 2 weeks
- Required H. pylori eradication therapy during the study
- Had prior vaccination with G17DT or any other product with a similar mechanism of action
- Had a history of gastric or vagus nerve surgery
- Had any clinically significant laboratory abnormalities and medical conditions which were unexplained, or, in the opinion of the investigator, did not allow for safe entry of the subject into the study
- Had contraindications to intramuscular injections (e.g., bleeding disorders or treatment with anticoagulants [except for aspirin])
- Had serious and unstable cardiovascular or respiratory disease, other malignancy or any other condition that would have jeopardized subject safety or confounded the results
- Had a known hypersensitivity to diphtheria toxoid, G17DT, any of its components or any similar compound
- Had any other condition that might have influenced the plasma gastrin level (e.g., achlorhydria, Zollinger-Ellison syndrome)
- Had used of an investigational drug within the previous month
- Had taken treatments that alter the immune response such as radiotherapy, corticosteroids, and antineoplastic drugs (Inhaled corticosteroids were permitted.)
- Had conditions that impaired the immune response (e.g., acquired immune deficiency syndrome)
- Had a history of drug or alcohol abuse within the past year
- Was unable to accept a standard breakfast for dietary reasons
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
G17DT & Omeprazole
Arm Description
A 14-day washout period An Omeprazole Treatment Period 1 (Day -15 to Day -1) A G17DT treatment period (Day 0 to Day 85) An Omeprazole Treatment Period 2 (Day 86 to Day 100)
Outcomes
Primary Outcome Measures
Change in plasma gastrin level.
Compare basal and meal stimulated plasma gastrin levels before and after treatment with three intramuscular injections of 250 µg G17DT, with and without the concomitant administration of Omeprazole.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02518373
Brief Title
Effect of G17DT in Patients With Stage II/III Colorectal Cancer
Acronym
CC5
Official Title
An Open-label Volunteer Study of the Effect of G17DT on the Elevation of Plasma Gastrin Levels After Therapy With a Proton Pump Inhibitor (Omeperazole) in Patients With Treated Stage II/III Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
April 2000 (undefined)
Primary Completion Date
February 2001 (Actual)
Study Completion Date
February 2001 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cancer Advances Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This Phase 2 study was an open label, single-center 18-week study to compare basal and meal stimulated plasma gastrin levels before and after treatment with 3 intramuscular injections of 250 µg G17DT, with and without the concomitant administration of Omeprazole.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
G17DT & Omeprazole
Arm Type
Experimental
Arm Description
A 14-day washout period
An Omeprazole Treatment Period 1 (Day -15 to Day -1)
A G17DT treatment period (Day 0 to Day 85)
An Omeprazole Treatment Period 2 (Day 86 to Day 100)
Intervention Type
Biological
Intervention Name(s)
G17DT
Other Intervention Name(s)
PAS, Gastrimmune
Intervention Description
G17DT is a therapeutic immunogen, formulated as a white, sterile, semi-viscous, water-in-oil emulsion (30:70 weight for weight). It was manufactured and supplied by Nova Laboratories Ltd., in glass ampoules containing 0.5 mL at a concentration of 1.25 mg/mL, as a single dose to be administered by intramuscular injection.
Intervention Type
Drug
Intervention Name(s)
Omeprazole
Intervention Description
Proton pump inhibitor used in the treatment of dyspepsia, peptic ulcer disease, gastroesophageal reflux disease, laryngopharyngeal reflux, and Zollinger-Ellison syndrome.
Primary Outcome Measure Information:
Title
Change in plasma gastrin level.
Description
Compare basal and meal stimulated plasma gastrin levels before and after treatment with three intramuscular injections of 250 µg G17DT, with and without the concomitant administration of Omeprazole.
Time Frame
up to Day 100
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female subjects aged 18 to 70 years, inclusive
Written informed consent was provided
Histologically confirmed Stage II/III colorectal cancer after radical surgery
A minimum of 3 months elapsed since completion of the chemotherapy for subjects who had received adjuvant chemotherapy
Subject had recovered from any toxic effects of chemotherapy
Exclusion Criteria:
Had a known local recurrence of colorectal cancer or presence of metastatic colorectal cancer lesions
Was using an inadequate method of contraception (determined at the discretion of the investigator), only for women of childbearing potential who were sexually active
Was unable to comply with the protocol
Was unable to abstain from H2 receptor antagonists, PPIs or anticholinergics medications for 2 weeks
Required H. pylori eradication therapy during the study
Had prior vaccination with G17DT or any other product with a similar mechanism of action
Had a history of gastric or vagus nerve surgery
Had any clinically significant laboratory abnormalities and medical conditions which were unexplained, or, in the opinion of the investigator, did not allow for safe entry of the subject into the study
Had contraindications to intramuscular injections (e.g., bleeding disorders or treatment with anticoagulants [except for aspirin])
Had serious and unstable cardiovascular or respiratory disease, other malignancy or any other condition that would have jeopardized subject safety or confounded the results
Had a known hypersensitivity to diphtheria toxoid, G17DT, any of its components or any similar compound
Had any other condition that might have influenced the plasma gastrin level (e.g., achlorhydria, Zollinger-Ellison syndrome)
Had used of an investigational drug within the previous month
Had taken treatments that alter the immune response such as radiotherapy, corticosteroids, and antineoplastic drugs (Inhaled corticosteroids were permitted.)
Had conditions that impaired the immune response (e.g., acquired immune deficiency syndrome)
Had a history of drug or alcohol abuse within the past year
Was unable to accept a standard breakfast for dietary reasons
12. IPD Sharing Statement
Learn more about this trial
Effect of G17DT in Patients With Stage II/III Colorectal Cancer
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