Clinical trial NCT02450032: Study to Determine the Antibody Response to 500µg G17DT in Treatment of Patients With Gastric Cancer
Official title: An Open, Multi-center Study to Determine the Antibody Response to 500µg G17DT Given at Weeks 0, 2, and 6 in the Treatment of Patients With Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Lead sponsor: Cancer Advances Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-21
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was designed to investigate the antibody response generated by a 500µg dose of G17DT in patients with gastric cancer.

Detailed description: Another study, GC2, initiated prior to the start of this study investigated the appropriate dose and dosing schedule for G17DT in patients with Stage I-III gastric cancer. The highest dose tested in the GC2 study was 250µg. This dose was well tolerated but was not considered sufficiently immunogenic. Since tolerability had not constrained dosing up to 250µg, the GC5 study was designed to investigate a 500µg dose administered as a regimen of 0, 2, and 6 weeks.

Eligibility criteria: Inclusion Criteria:

* Patients with histologically confirmed UICC Stage I, II or III gastric adenocarcinoma.
* Patients 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 patients aged 18 years or older.
* Life expectancy of at least 3 months.
* WHO Performance Status of 0 to 1.
* Written informed consent

Exclusion Criteria:

* Gastric surgery within four weeks of baseline (Week 0, visit 2) or gastric surgery anticipated during the period of the study.
* History of other malignant disease within the previous five years, except nonmelanomatous skin cancer or in situ carcinoma of the uterine cervix.
* Previous use within the last four weeks, concomitant use of anticipated use in the period of study, of any anti-cancer therapies.
* Concomitant use of immunosuppressants, including systemic (i.e. oral or injected) corticosteroids.
* Females who were pregnant, planning to become pregnant or lactating.
* Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrollment or during this study.
* Previous G17DT treatment.
* Haematologicial indicators:

Haemoglobin (Hb) \< 10g/dL White blood cell count (WBC) \< 4.0 x 10\^9/L Platelets \< 100 x 10\^9/L

Primary outcomes:
measure: Antibody Levels
timeFrame: Through Week 12
measure: Injection Site Reaction
timeFrame: Up to Week 12
measure: Change in Subject's World Health Organization Performance Status
timeFrame: Through Week 12
Secondary outcomes:
measure: Overall Survival
timeFrame: From date of randomization up to Week 24 or until death
measure: Adverse Events
timeFrame: Through week 12
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary
Study officials:
affiliation: Glasgow Royal Infirmary
name: Robert Stuart, MB ChB
role: PRINCIPAL_INVESTIGATOR
References: