Study to Assess Tolerability and Safety and Antibody Response to G17DT in Gastric Cancer Patients

Study Overview
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Brief Summary
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Open-label, multicenter study to assess 250µg/0.2ml G17DT injection at weeks 0, 2 and 6. At or after week 20 and up to and including week 44. Subjects who raised antibodies to G17DT were given an additional dose of 125µg/0.1ml or 250µg/0.2ml G17DT between weeks 20-44 (study duration 52 weeks).

Official Title
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An Open, Multi-centre Study to Determine the Tolerability, Safety and Antibody Response Resulting From G17DT at 250mcg at Weeks 0, 2 and 6 With a Booster of 125mcg or 250mcg Given to Patients With Stage I - III Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Biological: G17DT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who had had curative resection for histologically confirmed Stage I, II, or III gastric carcinoma or carcinoma of the oesophagogastric junciton. Male or female patients over 18 years of age. Patients with a life expectancy of at least four months. Karnofsky index for performance status of >70% Patients must have given written informed consent. Exclusion Criteria: Gastric or junctional surgery within three weeks of baseline (week 0) or gastric or junctional surgery anticipated in the study period. History of other malignant disease within the previous five years, except non-melanomatous skin cancer or in situ carcinoma of the uterine cervix. Previous use (within the six weeks prior to the screening visit of the study), concomitant use, or anticipated use (up to week 16), of chemotherapy or immunotherapy. Previous use (within the six weeks prior to the screening visit of the study), concomitant use, or anticipated use (up to week 16), of radiotherapy or any other anti-cancer therapy. Previous use (within the four weeks prior to the screening visit of the study), concomitant use, or anticipated use (up to week 16), of immunosuppressants, including systemic corticosteroids. Known immunodeficiency. Females who were pregnant, planning to become pregnant or lactating. Women, who in the opinion of the investigator were of child bearing potential, were to have a negative pregnancy test before study drug administration. Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or up to week 16 during this study. Previous G17DT treatment. Haematological indicators: Haemoglobin <10.0g/dl Neutrophils < 2.0 x 109/l Platelets <100 x 109/l

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 250µg dose treatment<br>Subjects were treated with a 250mcg/0.2ml G17DT injection at weeks 0, 2 and 6. | Biological: G17DT<br> <br> * Other names: Gastrimmune, Insegia, PAS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurable Gastrin-17 Antibody Titer |  | Up to Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Injection tolerability | Subjects were monitored for injection site reactions and/or swelling at the injections site. | Up to Week 52 | 
| Overall Survival from date of randomization to death or end of study |  | Up to December 2002 |