Dose-ranging Study to Evaluate Antibody Response to G17DT in Patients With Gastric Cancer

August 10, 2015 updated by: Cancer Advances Inc.

An Open, Dose-ranging, Multicenter Study to Determine the Antibody Response to G17DT and Its Safety and Tolerability in the Treatment of Patients With Gastric Cancer

An open, dose-ranging, multiple dose, multi-centre study in patients with Stage I-III or Stage IV gastric cancer. Twelve patients in each of 5 treatment groups were to receive three injections at weeks 0, 2 and 6 with provision for a single booster injection in an extension study period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Stage I-III Criteria-

  • Patients aged 18 years or over who had had a macroscopically curative resection for gastric adenocarcinoma.

  • Absence of metastatic disease evident from:

    • physical examination
    • the most recent chest X-ray
    • abdominal CT or ultrasound scan
  • Life expectancy of at least 3 months
  • WHO performance status of 0 to 1
  • Written informed consent given

Stage IV Criteria-

  • Patients aged 18 years or over with Stage IV gastric cancer: carcinoma with the primary tumour invading the adjacent structures and/or involvement of more than 15 regional lymph nodes and/or distant metastases
  • Life expectancy of at least 3 months
  • WHO performance status of 0 to 2
  • Written informed consent given

Exclusion Criteria:

  • History of other malignant disease except non-melanomatous skin cancer or in situ carcinoma of the uterine cervix Recurrent gastric cancer following previous surgery Presence of metastatic disease: peritoneal deposits or involved lymph nodes outside the limit of resection
  • Previous use, concomitant use or anticipated use in the period of the study, of any anti-cancer therapies
  • Concomitant use of immunosuppressants, including systemic (ie oral or injected) corticosteroids
  • Females who were pregnant, planning to become pregnant or lactating
  • Patients who were taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during this study
  • Previous G17DT treatment

  • Haematological indicators:

    • Haemoglobin <10.0g/dl
    • White blood cell count <4.0 x 109/l
    • Platelets <100 x 109/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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 10µg, Stage I-III
10µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer.
Drug: G17DT
Other Names:
  • Gastrimmune, Insegia, PAS
Experimental: 100µg, Stage I-III
100µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer.
Drug: G17DT
Other Names:
  • Gastrimmune, Insegia, PAS
Experimental: 250µg, Stage I-III
250µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer.
Drug: G17DT
Other Names:
  • Gastrimmune, Insegia, PAS
Experimental: 100µg, Stage IV
100µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer.
Drug: G17DT
Other Names:
  • Gastrimmune, Insegia, PAS
Experimental: 250µg, Stage IV
250µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer.
Drug: G17DT
Other Names:
  • Gastrimmune, Insegia, PAS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurable Antibody Titer
Time Frame: Up to Week 12
Up to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival from date of randomization to death or end of study
Time Frame: Up to Last Patient Last Visit, January 2001
Patients were scheduled to attend follow-up visits every four weeks after completion of the 12-week core period of the study and to continue until the patient was discharged from the study or declined further follow-up.
Up to Last Patient Last Visit, January 2001
Injection Site Reaction
Time Frame: Through Week 12
A physical examination for the presence of an abcess at the injection site was performed on each patient to assess tolerability to treatment at every posttreatment visit from Week 0 to Week 12.
Through Week 12

Collaborators and Investigators

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

Sponsor

Cancer Advances Inc.

Collaborators

Clinical Project Services
MPS Research Unit

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

September 1, 1998

Primary Completion (Actual)

January 1, 2001

Study Completion (Actual)

January 1, 2001

Study Registration Dates

First Submitted

May 15, 2015

First Submitted That Met QC Criteria

August 10, 2015

First Posted (Estimate)

August 13, 2015

Study Record Updates

Last Update Posted (Estimate)

August 13, 2015

Last Update Submitted That Met QC Criteria

August 10, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GC2

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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