Dose-ranging Study to Evaluate Antibody Response to G17DT in Patients With Gastric Cancer

Study Overview
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Brief Summary
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An open, dose-ranging, multiple dose, multi-centre study in patients with Stage I-III or Stage IV gastric cancer. Twelve patients in each of 5 treatment groups were to receive three injections at weeks 0, 2 and 6 with provision for a single booster injection in an extension study period.

Official Title
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An Open, Dose-ranging, Multicenter Study to Determine the Antibody Response to G17DT and Its Safety and Tolerability in the Treatment of Patients With Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: G17DT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stage I-III Criteria- Patients aged 18 years or over who had had a macroscopically curative resection for gastric adenocarcinoma. Absence of metastatic disease evident from: physical examination the most recent chest X-ray abdominal CT or ultrasound scan Life expectancy of at least 3 months WHO performance status of 0 to 1 Written informed consent given Stage IV Criteria- Patients aged 18 years or over with Stage IV gastric cancer: carcinoma with the primary tumour invading the adjacent structures and/or involvement of more than 15 regional lymph nodes and/or distant metastases Life expectancy of at least 3 months WHO performance status of 0 to 2 Written informed consent given Exclusion Criteria: History of other malignant disease except non-melanomatous skin cancer or in situ carcinoma of the uterine cervix Recurrent gastric cancer following previous surgery Presence of metastatic disease: peritoneal deposits or involved lymph nodes outside the limit of resection Previous use, concomitant use or anticipated use in the period of the study, of any anti-cancer therapies Concomitant use of immunosuppressants, including systemic (ie oral or injected) corticosteroids Females who were pregnant, planning to become pregnant or lactating Patients who were taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during this study Previous G17DT treatment Haematological indicators: Haemoglobin <10.0g/dl White blood cell count <4.0 x 109/l Platelets <100 x 109/l

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10µg, Stage I-III<br>10µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer. | Drug: G17DT<br> <br> * Other names: Gastrimmune, Insegia, PAS;|
| Experimental: 100µg, Stage I-III<br>100µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer. | Drug: G17DT<br> <br> * Other names: Gastrimmune, Insegia, PAS;|
| Experimental: 250µg, Stage I-III<br>250µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer. | Drug: G17DT<br> <br> * Other names: Gastrimmune, Insegia, PAS;|
| Experimental: 100µg, Stage IV<br>100µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer. | Drug: G17DT<br> <br> * Other names: Gastrimmune, Insegia, PAS;|
| Experimental: 250µg, Stage IV<br>250µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer. | Drug: 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 Antibody Titer |  | Up to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival from date of randomization to death or end of study | Patients were scheduled to attend follow-up visits every four weeks after completion of the 12-week core period of the study and to continue until the patient was discharged from the study or declined further follow-up. | Up to Last Patient Last Visit, January 2001 | 
| Injection Site Reaction | A physical examination for the presence of an abcess at the injection site was performed on each patient to assess tolerability to treatment at every posttreatment visit from Week 0 to Week 12. | Through Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric Cancer, G17DT, PAS, Insegia, Gastrimmune