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

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
G17DT
Sponsored by
Cancer Advances Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, stomach neoplasms,

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Group 1

    Group 2

    Group 3

    Group 4

    Arm Description

    G17DT; 250 µg dose administered at 0, 1, and 3 weeks.

    G17DT; 100 µg dose administered at 0, 1, and 3 weeks.

    G17DT; 500 µg dose administered at 0, 1, and 3 weeks.

    G17DT; 500 µg dose administered 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
    An examination was performed to assess injection site tolerability at every posttreatment visit from Week 1 to Week 12 (end of core phase).
    World Health Organization (WHO) Performance Status
    WHO performance status was monitored up to Week 12 to compare final status with baseline status.
    Diptheria Toxoid Antibody Levels
    Diptheria toxoid antibody levels were measured at screening and at Week 12 to assess toxicity from Diptheria toxoid.

    Secondary Outcome Measures

    Adverse Events
    Any adverse events that were reported during the study

    Full Information

    First Posted
    August 27, 2014
    Last Updated
    September 5, 2014
    Sponsor
    Cancer Advances Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02233712
    Brief Title
    Open-label, Dose-finding Study to Determine Antibody Response to G17DT Treatment in Patients With Gastric Cancer.
    Acronym
    GC3
    Official Title
    An Open-label, Dose-finding, Schedule-changing, Multi-center Study to Determine the Antibody Response to G17DT Treatment of Patients With Gastric Cancer.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1999 (undefined)
    Primary Completion Date
    March 2000 (Actual)
    Study Completion Date
    undefined (undefined)

    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastric Cancer
    Keywords
    gastric cancer, stomach neoplasms,

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    33 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Experimental
    Arm Description
    G17DT; 250 µg dose administered at 0, 1, and 3 weeks.
    Arm Title
    Group 2
    Arm Type
    Experimental
    Arm Description
    G17DT; 100 µg dose administered at 0, 1, and 3 weeks.
    Arm Title
    Group 3
    Arm Type
    Experimental
    Arm Description
    G17DT; 500 µg dose administered at 0, 1, and 3 weeks.
    Arm Title
    Group 4
    Arm Type
    Experimental
    Arm Description
    G17DT; 500 µg dose administered at 0, 2, and 6 weeks.
    Intervention Type
    Biological
    Intervention Name(s)
    G17DT
    Other Intervention Name(s)
    Polyclonal Antibody Stimulator (PAS)
    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
    Up to Week 24
    Title
    Injection Site Reaction
    Description
    An examination was performed to assess injection site tolerability at every posttreatment visit from Week 1 to Week 12 (end of core phase).
    Time Frame
    Up to Week 12
    Title
    World Health Organization (WHO) Performance Status
    Description
    WHO performance status was monitored up to Week 12 to compare final status with baseline status.
    Time Frame
    Up to Week 12
    Title
    Diptheria Toxoid Antibody Levels
    Description
    Diptheria toxoid antibody levels were measured at screening and at Week 12 to assess toxicity from Diptheria toxoid.
    Time Frame
    Up to Week 12
    Secondary Outcome Measure Information:
    Title
    Adverse Events
    Description
    Any adverse events that were reported during the study
    Time Frame
    Up to Week 24

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Peter G McCulloch, MB, ChB
    Organizational Affiliation
    University Hospital Aintree
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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