Two Center Study to Determine Effect of G17DT on Plasma Gastrin Levels in Patients With Colorectal Cancer. (CC4)

Phase II, Randomised, Double-blind, Placebo-controlled, Parallel Group, Two Centre Study to Determine the Effect of G17DT on Plasma Gastrin Levels in Patients With Colorectal Cancer.

Pancreatic, gastric, and colorectal cancers have all been shown to overexpress the gastrin gene and to be sensitive to the trophic effects of the gastrin in animal models. The hypothesis of this study is that G17DT will elicit specific and high-affinity antibodies that will bind gastrin-17, thus preventing the trophic activity of cancer cells.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Biological: Placebo Comparator; Biological: G17DT

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Merseyside
    • Liverpool, Merseyside, United Kingdom
      • University Hospital Aintree

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with histologically confirmed colorectal carcinoma for whom no other anti-cancer treatment was anticipated during the three month period of study.
• Patients taking a proton pump inhibitor at a fixed daily dose which had remained unchanged for at least six weeks preceding screening and was not anticipated to change during the study.
• Proton pump inhibitor compliance of ~70% (to be measured between screening and baseline (week 0)).
• Male or female patients from 18 to 65 years of age.
• Patients with a life expectancy of over three months.
• World Health Organisation (WHO) Performance Status of 0 to 1.
• Written informed consent given.

Exclusion Criteria:

• Patients in receipt of histamine H2-receptor (H2 receptor) antagonists or any other antacid therapy, other than a proton pump inhibitor at a stable dose.
• Patients with any other factor likely to alter intra-gastric acidity e.g. previous gastric surgery, including vagotomy or anatomically abnormal upper gastrointestinal tract.
• History of other malignant disease within the previous five years, except non- melanomatous skin cancer or in situ carcinoma of the uterine cervix.
• Previous use within the last four weeks, concomitant use or anticipated use in the period of the study of radiotherapy or chemotherapy.
• Concomitant use of immunosuppressants, including systemic (i .e. oral or injected) corticosteroids.
• Females who were pregnant, planning to become pregnant or lactating. Women, who in the opinion of the investigator were of child bearing potential, were to have a negative pregnancy test before study drug administration.
• Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during the study.
• Previous G 17DT treatment.
• Haematological indicators:

Haemoglobin <10.0 g/dL White blood cell count <4.0 x 109/L Platelets < 100 x 1 09/L

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: G17DT; Three 250 µg injections over a six week period (weeks 0,2 and 6)	Biological: G17DT
PLACEBO_COMPARATOR: Placebo; Three 250 µg injections of a placebo over a six week period (weeks 0,2 and 6)	Biological: Placebo Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibody Levels	Assess effects of gastrin-17 antibodies in response to G17DT immunization.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pharmacodynamic	measure production of gastrin-17 antibodies.	12 weeks
Number of Participants with Serious and Non-Serious Adverse Events	Adverse events, defined as any event involving adverse reactions, illnesses with onset during the study, or exacerbations of pre-existing illnesses, were assessed at each visit.	12 weeks

Collaborators and Investigators

• Sponsor: Cancer Advances Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2000
• Primary Completion (ACTUAL): August 1, 2001
• Study Completion (ACTUAL): November 1, 2001

Study Registration Dates

• First Submitted: July 2, 2014
• First Submitted That Met QC Criteria: August 20, 2014
• First Posted (ESTIMATE): August 22, 2014

Study Record Updates

• Last Update Posted (ACTUAL): June 20, 2017
• Last Update Submitted That Met QC Criteria: June 19, 2017
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CC4