Back to resultsStudy to Assess Safety and Tolerability of G17DT in Patients With Colorectal Adenocarcinoma. (CC1A&B)
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
G17DT
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically verified adenocarcinoma of the colon or rectum
- Recurrent/ metastatic disease not amenable to curative surgery and/or radiotherapy
- measurable/ evaluable lesions
- Life expectancy > 3 months
- Karnofsky index > 50% or WHO performance rating of 0-2
Biochemical markers:
- renal function < 25% above upper limit of normal range (creatinine, 140 imol/1 unless malignant involvement proven)
- liver function < 25% above upper limit of normal range (bilirubin ~25 mcmol/1 unless malignant involvement proven)
Haematological status:
- haemoglobin, 11 g/ dl
- WBC, 4 X 109/1
- platelets, 100 x 109/l
- Written consent
Exclusion Criteria:
- Other concomitant malignant disease except treated basal cell carcinoma of the skin or cancer of the uterine cervix stage 0-1
- H 2 receptor antagonist or proton pump inhibitor therapy
- Previous gastric surgery (including vagotomy)
- Active uncontrolled infection
- Autoimmune disorders
- Anticancer treatment within the last three months unless progression of the disease occurred in the interim
- Women of child-bearing age
- Patient is a poor medical risk because of non-malignant systemic disease
- Previous radiotherapy to all measurable or evaluable lesions.
Sites / Locations
- University Hospital, Queen's Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1
Group 2
Arm Description
One injection of G17DT followed by up to three booster injections depending on antibody response over 16 week period
Three injections of G17DT with option of one booster after 16 weeks
Outcomes
Primary Outcome Measures
Number of participants with adverse effects
Secondary Outcome Measures
Measure serum anti gastrin-17 antibodies to determine immunological response to medication
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02181465
Brief Title
Study to Assess Safety and Tolerability of G17DT in Patients With Colorectal Adenocarcinoma.
Acronym
CC1A&B
Official Title
Phase II, Open Label, Single Center, Two Arm Study Study to Assess the Safety, Tolerance and Efficacy of a 2 mg Dose of G17DT Via Intramuscular Injection in Patients With Advanced Metastatic Colorectal Adenocarcinoma.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
October 1993 (undefined)
Primary Completion Date
May 1994 (Actual)
Study Completion Date
May 1994 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cancer Advances Inc.
4. Oversight
5. Study Description
Brief Summary
Pancreatic, gastric, and colorectal cancers have all been shown to overexpress the gastrin gene and to be sensitive to the trophic effects of the gastrin in animal models. The hypothesis of this study is that G17DT will elicit specific and high-affinity antibodies that will bind gastrin-17, thus preventing the trophic activity of cancer cells.
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
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
One injection of G17DT followed by up to three booster injections depending on antibody response over 16 week period
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Three injections of G17DT with option of one booster after 16 weeks
Intervention Type
Biological
Intervention Name(s)
G17DT
Primary Outcome Measure Information:
Title
Number of participants with adverse effects
Time Frame
Up to week 16
Secondary Outcome Measure Information:
Title
Measure serum anti gastrin-17 antibodies to determine immunological response to medication
Time Frame
Up to week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
81 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically verified adenocarcinoma of the colon or rectum
Recurrent/ metastatic disease not amenable to curative surgery and/or radiotherapy
measurable/ evaluable lesions
Life expectancy > 3 months
Karnofsky index > 50% or WHO performance rating of 0-2
Biochemical markers:
renal function < 25% above upper limit of normal range (creatinine, 140 imol/1 unless malignant involvement proven)
liver function < 25% above upper limit of normal range (bilirubin ~25 mcmol/1 unless malignant involvement proven)
Haematological status:
haemoglobin, 11 g/ dl
WBC, 4 X 109/1
platelets, 100 x 109/l
Written consent
Exclusion Criteria:
Other concomitant malignant disease except treated basal cell carcinoma of the skin or cancer of the uterine cervix stage 0-1
H 2 receptor antagonist or proton pump inhibitor therapy
Previous gastric surgery (including vagotomy)
Active uncontrolled infection
Autoimmune disorders
Anticancer treatment within the last three months unless progression of the disease occurred in the interim
Women of child-bearing age
Patient is a poor medical risk because of non-malignant systemic disease
Previous radiotherapy to all measurable or evaluable lesions.
Facility Information:
Facility Name
University Hospital, Queen's Medical Centre
City
Nottingham
State/Province
Nottinghamshire
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Study to Assess Safety and Tolerability of G17DT in Patients With Colorectal Adenocarcinoma.
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