Study to Assess Safety and Tolerability of G17DT in Patients With Colorectal Adenocarcinoma.

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Biological: G17DT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 81 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>One injection of G17DT followed by up to three booster injections depending on antibody response over 16 week period | Biological: G17DT<br> <br> |
| Experimental: Group 2<br>Three injections of G17DT with option of one booster after 16 weeks | Biological: G17DT<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse effects |  | Up to week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure serum anti gastrin-17 antibodies to determine immunological response to medication |  | Up to week 16 |