A Study of the Safety and Tolerance of Three Doses of G17DT in Metastatic Colorectal Cancer (CC1C)

Study of the Safety and Tolerance of Three Doses of G17DT in Patients With Metastatic Colorectal Cancer.

This study was designed to investigate the safety and tolerance of three doses (100µg, 200µg, 500µg) of G17DT for the treatment of patients with colorectal cancer.

Study Overview

• Status: Terminated
• Conditions: Colorectal Cancer
• Intervention / Treatment: Biological: G17DT

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Patients aged 18 years or over with histologically verified adenocarcinoma of colon or rectum.
• Recurrent of metastatic disease not amenable to curative surgery and/or radiotherapy.
• Life expectancy greater than 3 months.
• Karnofsky Index Score greater than or equal to 50%.
• Written informed consent obtained.

Exclusion Criteria:

• Neoplastic lesions other than colorectal cancer (except treated basal cell carcinoma of the skin or cancer of the uterine cervix, through Stage I.
• Acute intercurrent illness.
• Patient considered to be a medical risk because of non-malignant systemic disease or grossly abnormal laboratory results.
• Patients who had received any other anticancer therapy within 3 months.
• Factor liable to alter the serum gastrin concentration or affect intra-gastric acidity, for instance concomitant therapy with H2 receptor antagonist drugs, proton pump inhibitors, or previous gastric surgery.
• Patients immunologically compromised including those on corticosteroid therapy.
• Women of child-bearing age.
• Positive immediate hypersensitivity reaction to skin testing with study medication.
• Patients unable to complete the diary book
• Haematogical Status Haemoglobin count less than 10g/dL White Blood Cell count less than 4.0 x 10^9/L Platelet count less than 100 x 10^9/L

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 100µg dose of G17DT; Patients in this arm received a 100µg dose of G17DT via intramuscular injection.	Biological: G17DT; Other Names: Polyclonal Antibody Stimulator
Experimental: 200µg dose of G17DT; Patients in this arm received a 200 µg dose of G17DT via intramuscular injection.	Biological: G17DT; Other Names: Polyclonal Antibody Stimulator
Experimental: 500µg dose of G17DT; Patients in this arm received a 500µg dose of G17DT via intramuscular injection.	Biological: G17DT; Other Names: Polyclonal Antibody Stimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibody Levels	Gastrin-17 antibodies are produced as a result of treatment with G17DT and the proportion of patients producing gastrin-17 antibodies was considered to be an appropriate measure of the immunogenicity of the dosing schedule under study.	Through Week 12
Injection Site Reaction	An examination was performed to assess injection site tolerability at every posttreatment visit.	Through Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra-gastric pH	Compare the pre-immunization 24-hour intra-gastric pH with post-immunization profiles.	Through Week 8

Collaborators and Investigators

• Sponsor: Cancer Advances Inc.
• Investigators: Principal Investigator: J D Hardcastle, MChir, FRCP, FRCS, University of Nottingham

Study record dates

Study Major Dates

• Study Start: May 1, 1994
• Primary Completion (Actual): October 1, 1994

Study Registration Dates

• First Submitted: August 27, 2014
• First Submitted That Met QC Criteria: August 28, 2014
• First Posted (Estimate): August 29, 2014

Study Record Updates

• Last Update Posted (Estimate): August 29, 2014
• Last Update Submitted That Met QC Criteria: August 28, 2014
• 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: CC1C