A Study of the Safety and Tolerance of Three Doses of G17DT in Metastatic Colorectal Cancer (CC1C)
Primary Purpose
Colorectal Cancer
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
G17DT
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
100µg dose of G17DT
200µg dose of G17DT
500µg dose of G17DT
Arm Description
Patients in this arm received a 100µg dose of G17DT via intramuscular injection.
Patients in this arm received a 200 µg dose of G17DT via intramuscular injection.
Patients in this arm received a 500µg dose of G17DT via intramuscular injection.
Outcomes
Primary Outcome Measures
Injection Site Reaction
An examination was performed to assess injection site tolerability at every posttreatment visit.
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.
Secondary Outcome Measures
Intra-gastric pH
Compare the pre-immunization 24-hour intra-gastric pH with post-immunization profiles.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02228785
Brief Title
A Study of the Safety and Tolerance of Three Doses of G17DT in Metastatic Colorectal Cancer
Acronym
CC1C
Official Title
Study of the Safety and Tolerance of Three Doses of G17DT in Patients With Metastatic Colorectal Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Why Stopped
Poor local tolerance to injection.
Study Start Date
May 1994 (undefined)
Primary Completion Date
October 1994 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cancer Advances Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
100µg dose of G17DT
Arm Type
Experimental
Arm Description
Patients in this arm received a 100µg dose of G17DT via intramuscular injection.
Arm Title
200µg dose of G17DT
Arm Type
Experimental
Arm Description
Patients in this arm received a 200 µg dose of G17DT via intramuscular injection.
Arm Title
500µg dose of G17DT
Arm Type
Experimental
Arm Description
Patients in this arm received a 500µg dose of G17DT via intramuscular injection.
Intervention Type
Biological
Intervention Name(s)
G17DT
Other Intervention Name(s)
Polyclonal Antibody Stimulator
Primary Outcome Measure Information:
Title
Injection Site Reaction
Description
An examination was performed to assess injection site tolerability at every posttreatment visit.
Time Frame
Through Week 12
Title
Antibody Levels
Description
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.
Time Frame
Through Week 12
Secondary Outcome Measure Information:
Title
Intra-gastric pH
Description
Compare the pre-immunization 24-hour intra-gastric pH with post-immunization profiles.
Time Frame
Through Week 8
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J D Hardcastle, MChir, FRCP, FRCS
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
A Study of the Safety and Tolerance of Three Doses of G17DT in Metastatic Colorectal Cancer
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