Open-label, Dose-finding Study to Determine Antibody Response to G17DT Treatment in Patients With Gastric Cancer.

Study Overview
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Brief Summary
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An open label, dose-finding, schedule-changing, sequential, multiple dose, multi-center study in patients with Stage I-III gastric cancer. The first group of patients received a starting dose of 250 µg at weeks 0, 1, and 3. Thereafter, allocation to treatment with 100 µg or 500 µg was based on antibody response and dose tolerability.

Official Title
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An Open-label, Dose-finding, Schedule-changing, Multi-center Study to Determine the Antibody Response to G17DT Treatment of Patients With 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: Histologically confirmed UICC Stage I, II or III gastric adenocarcinoma. Must have had a macroscopically curative resection for gastric cancer with absence of metastatic disease at the time of entry to the trial Male or female and over 18 years of age Must have a life expectancy of at least three months World Health Organization Performance Status of 0 to 1 Given written conformed consent Exclusion Criteria: Gastric surgery within four weeks of baseline (week 0) or gastric surgery anticipated in the period of the study 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 last four weeks, concomitant use or anticipated use in the period of the study, of any anti-cancer therapies Concomitant use of immunosuppressants, including systemic (i.e. oral or injected) corticosteroids Females who pregnant, planning to become pregnant or lactating Taking part in another study involving an investigational or licensed drug or device in the three months preceding enrollment or during this study Previously received G17DT treatment Haemoglobin (Hb) < 10.0 g/dL White blood cell count (WBC) < 4.0 x 10^9/L Platelets < 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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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>G17DT; 250 µg dose administered at 0, 1, and 3 weeks. | Biological: G17DT<br> <br> * Other names: Polyclonal Antibody Stimulator (PAS);|
| Experimental: Group 2<br>G17DT; 100 µg dose administered at 0, 1, and 3 weeks. | Biological: G17DT<br> <br> * Other names: Polyclonal Antibody Stimulator (PAS);|
| Experimental: Group 3<br>G17DT; 500 µg dose administered at 0, 1, and 3 weeks. | Biological: G17DT<br> <br> * Other names: Polyclonal Antibody Stimulator (PAS);|
| Experimental: Group 4<br>G17DT; 500 µg dose administered at 0, 2, and 6 weeks. | Biological: G17DT<br> <br> * Other names: Polyclonal Antibody Stimulator (PAS);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to Week 24 | 
| Injection Site Reaction | An examination was performed to assess injection site tolerability at every posttreatment visit from Week 1 to Week 12 (end of core phase). | Up to Week 12 | 
| World Health Organization (WHO) Performance Status | WHO performance status was monitored up to Week 12 to compare final status with baseline status. | Up to Week 12 | 
| Diptheria Toxoid Antibody Levels | Diptheria toxoid antibody levels were measured at screening and at Week 12 to assess toxicity from Diptheria toxoid. | Up to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Any adverse events that were reported during the study | Up to Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, stomach neoplasms,