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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | G17DT; 250 µg dose administered at 0, 1, and 3 weeks. |
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| Group 2 | Experimental | G17DT; 100 µg dose administered at 0, 1, and 3 weeks. |
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| Group 3 | Experimental | G17DT; 500 µg dose administered at 0, 1, and 3 weeks. |
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| Group 4 | Experimental | G17DT; 500 µg dose administered at 0, 2, and 6 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G17DT | Biological |
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Any adverse events that were reported during the study | Up to Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter G McCulloch, MB, ChB | University Hospital Aintree | Principal Investigator |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |