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

NCT02228785 | Terminated Phase 2 DMC

• 1 other identifier: CC1C
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• Injection Site Reaction

  An examination was performed to assess injection site tolerability at every posttreatment visit.

  Through Week 12

• 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

Secondary Outcomes (1)

• Intra-gastric pH

  Through Week 8

Study Arms (3)

100µg dose of G17DT

EXPERIMENTAL

Patients in this arm received a 100µg dose of G17DT via intramuscular injection.

Biological: G17DT

200µg dose of G17DT

EXPERIMENTAL

Patients in this arm received a 200 µg dose of G17DT via intramuscular injection.

Biological: G17DT

500µg dose of G17DT

EXPERIMENTAL

Patients in this arm received a 500µg dose of G17DT via intramuscular injection.

Biological: G17DT

Interventions

G17DT BIOLOGICAL

Also known as: Polyclonal Antibody Stimulator

100µg dose of G17DT; 200µg dose of G17DT; 500µg dose of G17DT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cancer Advances Inc.: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• J D Hardcastle, MChir, FRCP, FRCS

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2014
• First Posted: August 29, 2014
• Study Start: May 1, 1994
• Primary Completion: October 1, 1994
• Last Updated: August 29, 2014

Record last verified: 2014-08