Open-label, Dose-finding Study to Determine Antibody Response to G17DT Treatment in Patients With Gastric Cancer. (GC3)

September 5, 2014 updated by: Cancer Advances Inc.

An Open-label, Dose-finding, Schedule-changing, Multi-center Study to Determine the Antibody Response to G17DT Treatment of Patients With Gastric Cancer.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 2

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:

  • 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

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
G17DT; 250 µg dose administered at 0, 1, and 3 weeks.
Biological: G17DT
Other Names:
  • Polyclonal Antibody Stimulator (PAS)
Experimental: Group 2
G17DT; 100 µg dose administered at 0, 1, and 3 weeks.
Biological: G17DT
Other Names:
  • Polyclonal Antibody Stimulator (PAS)
Experimental: Group 3
G17DT; 500 µg dose administered at 0, 1, and 3 weeks.
Biological: G17DT
Other Names:
  • Polyclonal Antibody Stimulator (PAS)
Experimental: Group 4
G17DT; 500 µg dose administered at 0, 2, and 6 weeks.
Biological: G17DT
Other Names:
  • Polyclonal Antibody Stimulator (PAS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibody Levels
Time Frame: 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.
Up to Week 24
Injection Site Reaction
Time Frame: 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).
Up to Week 12
World Health Organization (WHO) Performance Status
Time Frame: Up to Week 12
WHO performance status was monitored up to Week 12 to compare final status with baseline status.
Up to Week 12
Diptheria Toxoid Antibody Levels
Time Frame: Up to Week 12
Diptheria toxoid antibody levels were measured at screening and at Week 12 to assess toxicity from Diptheria toxoid.
Up to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: Up to Week 24
Any adverse events that were reported during the study
Up to Week 24

Collaborators and Investigators

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

Sponsor

Cancer Advances Inc.

Investigators

  • Principal Investigator: Peter G McCulloch, MB, ChB, University Hospital Aintree

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

August 1, 1999

Primary Completion (Actual)

March 1, 2000

Study Registration Dates

First Submitted

August 27, 2014

First Submitted That Met QC Criteria

September 5, 2014

First Posted (Estimate)

September 8, 2014

Study Record Updates

Last Update Posted (Estimate)

September 8, 2014

Last Update Submitted That Met QC Criteria

September 5, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GC3

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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