Gastric Cancer
Conditions
Keywords
Gastric Cancer, G17DT, PAS, Insegia, Gastrimmune
Brief summary
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.
Interventions
DRUGG17DT
Sponsors
Clinical Project Services
MPS Research Unit
Cancer Advances Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurable Antibody Titer | Up to Week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival from date of randomization to death or end of study | Up to Last Patient Last Visit, January 2001 | 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. |
| Injection Site Reaction | Through Week 12 | 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. |
Outcome results
None listed