Back to resultsStudy to Determine the Antibody Response to 500µg G17DT in Treatment of Patients With Gastric Cancer (GC5)
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
G17DT
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
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
Sites / Locations
- Glasgow Royal Infirmary
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
G17DT
Arm Description
Treatment with 500µg/ 0.4mL dose of G17DT administered by intramuscular injection at 0, 2, and 6 weeks.
Outcomes
Primary Outcome Measures
Antibody Levels
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
A physical examination for the presence of an abscess at the injection site was performed on each patient to assess tolerability to treatment at every posttreatment visit from Week 0 to Week 12.
Change in Subject's World Health Organization Performance Status
The subject's WHO performance status was evaluated at each visit up to Week 12 to assess changes in subject's ability complete normal daily activities.
Secondary Outcome Measures
Overall Survival
Vital status was monitored throughout the study. Patients were followed up to their death or the study completion date, 18 June 2001.
Adverse Events
All adverse events reported during the study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02450032
Brief Title
Study to Determine the Antibody Response to 500µg G17DT in Treatment of Patients With Gastric Cancer
Acronym
GC5
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
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
February 2000 (undefined)
Primary Completion Date
May 2001 (Actual)
Study Completion Date
May 2001 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cancer Advances Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
G17DT
Arm Type
Experimental
Arm Description
Treatment with 500µg/ 0.4mL dose of G17DT administered by intramuscular injection at 0, 2, and 6 weeks.
Intervention Type
Biological
Intervention Name(s)
G17DT
Other Intervention Name(s)
Polyclonal Antibody Stimulator
Primary Outcome Measure Information:
Title
Antibody Levels
Description
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.
Time Frame
Through Week 12
Title
Injection Site Reaction
Description
A physical examination for the presence of an abscess at the injection site was performed on each patient to assess tolerability to treatment at every posttreatment visit from Week 0 to Week 12.
Time Frame
Up to Week 12
Title
Change in Subject's World Health Organization Performance Status
Description
The subject's WHO performance status was evaluated at each visit up to Week 12 to assess changes in subject's ability complete normal daily activities.
Time Frame
Through Week 12
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Vital status was monitored throughout the study. Patients were followed up to their death or the study completion date, 18 June 2001.
Time Frame
From date of randomization up to Week 24 or until death
Title
Adverse Events
Description
All adverse events reported during the study.
Time Frame
Through week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Stuart, MB ChB
Organizational Affiliation
Glasgow Royal Infirmary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glasgow Royal Infirmary
City
Glasgow
ZIP/Postal Code
G31 2 ER
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Study to Determine the Antibody Response to 500µg G17DT in Treatment of Patients With Gastric Cancer
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