Open-label, Dose-finding Study to Determine Antibody Response to G17DT Treatment in Patients With Gastric Cancer.
- Conditions
- Gastric Cancer
- Interventions
- Biological: G17DT
- Registration Number
- NCT02233712
- Lead Sponsor
- Cancer Advances Inc.
- Brief Summary
An open label, dose-finding, schedule-changing, sequential, multiple dose, multi-center study in patients with Stage I-III gastric cancer. The first group of patients received a starting dose of 250 µg at weeks 0, 1, and 3. Thereafter, allocation to treatment with 100 µg or 500 µg was based on antibody response and dose tolerability.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- Histologically confirmed UICC Stage I, II or III gastric adenocarcinoma. Must have had a macroscopically curative resection for gastric cancer with absence of metastatic disease at the time of entry to the trial
- Male or female and over 18 years of age
- Must have a life expectancy of at least three months
- World Health Organization Performance Status of 0 to 1
- Given written conformed consent
- Gastric surgery within four weeks of baseline (week 0) or gastric surgery anticipated in the period of the study
- History of other malignant disease within the previous five years, except non-melanomatous skin cancer or in situ carcinoma of the uterine cervix
- Previous use within the last four weeks, concomitant use or anticipated use in the period of the study, of any anti-cancer therapies
- Concomitant use of immunosuppressants, including systemic (i.e. oral or injected) corticosteroids
- Females who pregnant, planning to become pregnant or lactating
- Taking part in another study involving an investigational or licensed drug or device in the three months preceding enrollment or during this study
- Previously received G17DT treatment
- Haemoglobin (Hb) < 10.0 g/dL White blood cell count (WBC) < 4.0 x 10^9/L Platelets < 100 x 10^9/L
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Group 1 G17DT G17DT; 250 µg dose administered at 0, 1, and 3 weeks. Group 3 G17DT G17DT; 500 µg dose administered at 0, 1, and 3 weeks. Group 2 G17DT G17DT; 100 µg dose administered at 0, 1, and 3 weeks. Group 4 G17DT G17DT; 500 µg dose administered at 0, 2, and 6 weeks.
- Primary Outcome Measures
Name Time Method Antibody Levels Up to Week 24 Gastrin-17 antibodies are produced as a result of treatment with G17DT and the proportion of patients producing gastrin-17 antibodies was considered to be an appropriate measure of the immunogenicity of the dosing schedule under study.
Injection Site Reaction Up to Week 12 An examination was performed to assess injection site tolerability at every posttreatment visit from Week 1 to Week 12 (end of core phase).
World Health Organization (WHO) Performance Status Up to Week 12 WHO performance status was monitored up to Week 12 to compare final status with baseline status.
Diptheria Toxoid Antibody Levels Up to Week 12 Diptheria toxoid antibody levels were measured at screening and at Week 12 to assess toxicity from Diptheria toxoid.
- Secondary Outcome Measures
Name Time Method Adverse Events Up to Week 24 Any adverse events that were reported during the study