Overview

Dose-ranging Study to Evaluate Antibody Response to G17DT in Patients With Gastric Cancer

Status:
Completed
Trial end date:
2001-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Cancer Advances Inc.
Collaborators:
Clinical Project Services
MPS Research Unit
Treatments:
Antibodies
Gastrins
Immunoglobulins
Criteria
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