Study to Determine the Antibody Response to 500µg G17DT in Treatment of Patients With Gastric Cancer (GC5)

May 20, 2015 updated by: Cancer Advances Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom, G31 2 ER
        • Glasgow Royal Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: G17DT
Treatment with 500µg/ 0.4mL dose of G17DT administered by intramuscular injection at 0, 2, and 6 weeks.
Biological: G17DT
Other Names:
  • Polyclonal Antibody Stimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibody Levels
Time Frame: Through Week 12
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.
Through Week 12
Injection Site Reaction
Time Frame: Up to Week 12
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.
Up to Week 12
Change in Subject's World Health Organization Performance Status
Time Frame: Through Week 12
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.
Through Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: From date of randomization up to Week 24 or until death
Vital status was monitored throughout the study. Patients were followed up to their death or the study completion date, 18 June 2001.
From date of randomization up to Week 24 or until death
Adverse Events
Time Frame: Through week 12
All adverse events reported during the study.
Through week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Advances Inc.

Investigators

  • Principal Investigator: Robert Stuart, MB ChB, Glasgow Royal Infirmary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2000

Primary Completion (Actual)

May 1, 2001

Study Completion (Actual)

May 1, 2001

Study Registration Dates

First Submitted

August 27, 2014

First Submitted That Met QC Criteria

May 20, 2015

First Posted (Estimate)

May 21, 2015

Study Record Updates

Last Update Posted (Estimate)

May 21, 2015

Last Update Submitted That Met QC Criteria

May 20, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GC5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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