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

Phase 2

Terminated

• Conditions: Colorectal Cancer
• Interventions: Biological: G17DT

• Registration Number: NCT02228785
• Lead Sponsor: Cancer Advances Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1994-05
• Primary Completion: 1994-10
• Status Verified: 2014-08
• Study First Submitted: 2014-08-27
• Study First Submitted QC: 2014-08-28
• Last Update Submitted: 2014-08-28
• Study First Posted: 2014-08-29
• Last Update Posted: 2014-08-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
200µg dose of G17DT	G17DT	Patients in this arm received a 200 µg dose of G17DT via intramuscular injection.
500µg dose of G17DT	G17DT	Patients in this arm received a 500µg dose of G17DT via intramuscular injection.
100µg dose of G17DT	G17DT	Patients in this arm received a 100µg dose of G17DT via intramuscular injection.

Primary Outcome Measures

Name	Time	Method
Antibody Levels	Through Week 12	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.
Injection Site Reaction	Through Week 12	An examination was performed to assess injection site tolerability at every posttreatment visit.

Secondary Outcome Measures

Name	Time	Method
Intra-gastric pH	Through Week 8	Compare the pre-immunization 24-hour intra-gastric pH with post-immunization profiles.