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

Study Overview
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Brief Summary
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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.

Official Title
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Study of the Safety and Tolerance of Three Doses of G17DT in Patients With Metastatic Colorectal Cancer.

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: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

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: Randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 100µg dose of G17DT<br>Patients in this arm received a 100µg dose of G17DT via intramuscular injection. | Biological: G17DT<br> <br> * Other names: Polyclonal Antibody Stimulator;|
| Experimental: 200µg dose of G17DT<br>Patients in this arm received a 200 µg dose of G17DT via intramuscular injection. | Biological: G17DT<br> <br> * Other names: Polyclonal Antibody Stimulator;|
| Experimental: 500µg dose of G17DT<br>Patients in this arm received a 500µg dose of G17DT via intramuscular injection. | Biological: G17DT<br> <br> * Other names: Polyclonal Antibody Stimulator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-gastric pH | Compare the pre-immunization 24-hour intra-gastric pH with post-immunization profiles. | Through Week 8 |