Gastric Cancer
Conditions
Brief summary
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).
Interventions
BIOLOGICALG17DT
Sponsors
PPD Development, LP
ChapelPharma Ltd
Cancer Advances Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurable Gastrin-17 Antibody Titer | Up to Week 52 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival from date of randomization to death or end of study | Up to December 2002 | — |
| Injection tolerability | Up to Week 52 | Subjects were monitored for injection site reactions and/or swelling at the injections site. |
Outcome results
None listed