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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

GC2

Status

Completed

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
All
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 24 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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