Gastric Cancer
Conditions
Keywords
gastric cancer, stomach neoplasms,
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.
Interventions
BIOLOGICALG17DT
Sponsors
Cancer Advances Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Up to Week 24 | Any adverse events that were reported during the study |
Outcome results
None listed