Dose-ranging Study to Evaluate Antibody Response to G17DT in Patients With Gastric Cancer
- Registration Number
- NCT02521649
- Lead Sponsor
- Cancer Advances Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Not specified
- Target Recruitment
- 52
Stage I-III Criteria-
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Patients aged 18 years or over who had had a macroscopically curative resection for gastric adenocarcinoma.
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Absence of metastatic disease evident from:
- physical examination
- the most recent chest X-ray
- abdominal CT or ultrasound scan
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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
-
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
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Previous use, concomitant use or anticipated use in the period of the study, of any anti-cancer therapies
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Concomitant use of immunosuppressants, including systemic (ie oral or injected) corticosteroids
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Females who were pregnant, planning to become pregnant or lactating
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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
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Previous G17DT treatment
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Haematological indicators:
- Haemoglobin <10.0g/dl
- White blood cell count <4.0 x 109/l
- Platelets <100 x 109/l
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 10µg, Stage I-III G17DT 10µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer. 100µg, Stage I-III G17DT 100µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer. 250µg, Stage I-III G17DT 250µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer. 250µg, Stage IV G17DT 250µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer. 100µg, Stage IV G17DT 100µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer.
- Primary Outcome Measures
Name Time Method Measurable Antibody Titer Up to Week 12
- Secondary Outcome Measures
Name Time Method 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.
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.