Dose-ranging Study to Evaluate Antibody Response to G17DT in Patients With Gastric Cancer
Sponsored by Cancer Advances Inc.
About this trial
Last updated 10 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 24 years ago
What is this trial about?
What are the participation requirements?
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