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A Study of the Safety and Tolerance of Three Doses of G17DT in Metastatic Colorectal Cancer (CC1C)

Primary Purpose

Colorectal Cancer

Status
Terminated
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 Colorectal Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Patients aged 18 years or over with histologically verified adenocarcinoma of colon or rectum.
  • Recurrent of metastatic disease not amenable to curative surgery and/or radiotherapy.
  • Life expectancy greater than 3 months.
  • Karnofsky Index Score greater than or equal to 50%.
  • Written informed consent obtained.

Exclusion Criteria:

  • Neoplastic lesions other than colorectal cancer (except treated basal cell carcinoma of the skin or cancer of the uterine cervix, through Stage I.
  • Acute intercurrent illness.
  • Patient considered to be a medical risk because of non-malignant systemic disease or grossly abnormal laboratory results.
  • Patients who had received any other anticancer therapy within 3 months.
  • Factor liable to alter the serum gastrin concentration or affect intra-gastric acidity, for instance concomitant therapy with H2 receptor antagonist drugs, proton pump inhibitors, or previous gastric surgery.
  • Patients immunologically compromised including those on corticosteroid therapy.
  • Women of child-bearing age.
  • Positive immediate hypersensitivity reaction to skin testing with study medication.
  • Patients unable to complete the diary book
  • Haematogical Status Haemoglobin count less than 10g/dL White Blood Cell count less than 4.0 x 10^9/L Platelet count less than 100 x 10^9/L

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    100µg dose of G17DT

    200µg dose of G17DT

    500µg dose of G17DT

    Arm Description

    Patients in this arm received a 100µg dose of G17DT via intramuscular injection.

    Patients in this arm received a 200 µg dose of G17DT via intramuscular injection.

    Patients in this arm received a 500µg dose of G17DT via intramuscular injection.

    Outcomes

    Primary Outcome Measures

    Injection Site Reaction
    An examination was performed to assess injection site tolerability at every posttreatment visit.
    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.

    Secondary Outcome Measures

    Intra-gastric pH
    Compare the pre-immunization 24-hour intra-gastric pH with post-immunization profiles.

    Full Information

    First Posted
    August 27, 2014
    Last Updated
    August 28, 2014
    Sponsor
    Cancer Advances Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02228785
    Brief Title
    A Study of the Safety and Tolerance of Three Doses of G17DT in Metastatic Colorectal Cancer
    Acronym
    CC1C
    Official Title
    Study of the Safety and Tolerance of Three Doses of G17DT in Patients With Metastatic Colorectal Cancer.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2014
    Overall Recruitment Status
    Terminated
    Why Stopped
    Poor local tolerance to injection.
    Study Start Date
    May 1994 (undefined)
    Primary Completion Date
    October 1994 (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
    This study was designed to investigate the safety and tolerance of three doses (100µg, 200µg, 500µg) of G17DT for the treatment of patients with colorectal cancer.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    5 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    100µg dose of G17DT
    Arm Type
    Experimental
    Arm Description
    Patients in this arm received a 100µg dose of G17DT via intramuscular injection.
    Arm Title
    200µg dose of G17DT
    Arm Type
    Experimental
    Arm Description
    Patients in this arm received a 200 µg dose of G17DT via intramuscular injection.
    Arm Title
    500µg dose of G17DT
    Arm Type
    Experimental
    Arm Description
    Patients in this arm received a 500µg dose of G17DT via intramuscular injection.
    Intervention Type
    Biological
    Intervention Name(s)
    G17DT
    Other Intervention Name(s)
    Polyclonal Antibody Stimulator
    Primary Outcome Measure Information:
    Title
    Injection Site Reaction
    Description
    An examination was performed to assess injection site tolerability at every posttreatment visit.
    Time Frame
    Through Week 12
    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
    Secondary Outcome Measure Information:
    Title
    Intra-gastric pH
    Description
    Compare the pre-immunization 24-hour intra-gastric pH with post-immunization profiles.
    Time Frame
    Through Week 8

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients aged 18 years or over with histologically verified adenocarcinoma of colon or rectum. Recurrent of metastatic disease not amenable to curative surgery and/or radiotherapy. Life expectancy greater than 3 months. Karnofsky Index Score greater than or equal to 50%. Written informed consent obtained. Exclusion Criteria: Neoplastic lesions other than colorectal cancer (except treated basal cell carcinoma of the skin or cancer of the uterine cervix, through Stage I. Acute intercurrent illness. Patient considered to be a medical risk because of non-malignant systemic disease or grossly abnormal laboratory results. Patients who had received any other anticancer therapy within 3 months. Factor liable to alter the serum gastrin concentration or affect intra-gastric acidity, for instance concomitant therapy with H2 receptor antagonist drugs, proton pump inhibitors, or previous gastric surgery. Patients immunologically compromised including those on corticosteroid therapy. Women of child-bearing age. Positive immediate hypersensitivity reaction to skin testing with study medication. Patients unable to complete the diary book Haematogical Status Haemoglobin count less than 10g/dL White Blood Cell count less than 4.0 x 10^9/L Platelet count less than 100 x 10^9/L
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    J D Hardcastle, MChir, FRCP, FRCS
    Organizational Affiliation
    University of Nottingham
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    A Study of the Safety and Tolerance of Three Doses of G17DT in Metastatic Colorectal Cancer

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