A Study of the Safety and Tolerance of Three Doses of G17DT in Metastatic Colorectal Cancer (CC1C)
August 28, 2014 updated by: Cancer Advances Inc.
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
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: None (Open Label)
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.
|
Other Names:
|
|
Experimental: 200µg dose of G17DT
Patients in this arm received a 200 µg dose of G17DT via intramuscular injection.
|
Other Names:
|
|
Experimental: 500µg dose of G17DT
Patients in this arm received a 500µg dose of G17DT via intramuscular injection.
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Antibody Levels
Time Frame: 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.
|
Through Week 12
|
|
Injection Site Reaction
Time Frame: Through Week 12
|
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
Time Frame: Through Week 8
|
Compare the pre-immunization 24-hour intra-gastric pH with post-immunization profiles.
|
Through Week 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: J D Hardcastle, MChir, FRCP, FRCS, University of Nottingham
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Other Study ID Numbers
- CC1C
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.