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

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, G17DT, PAS, Insegia, Gastrimmune

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Does not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    10µg, Stage I-III

    100µg, Stage I-III

    250µg, Stage I-III

    100µg, Stage IV

    250µg, Stage IV

    Arm Description

    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.

    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.

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Measurable Antibody Titer

    Secondary Outcome Measures

    Overall Survival from date of randomization to death or end of study
    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.
    Injection Site Reaction
    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.

    Full Information

    First Posted
    May 15, 2015
    Last Updated
    August 10, 2015
    Sponsor
    Cancer Advances Inc.
    Collaborators
    Clinical Project Services, MPS Research Unit
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02521649
    Brief Title
    Dose-ranging Study to Evaluate Antibody Response to G17DT in Patients With Gastric Cancer
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1998 (undefined)
    Primary Completion Date
    January 2001 (Actual)
    Study Completion Date
    January 2001 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Cancer Advances Inc.
    Collaborators
    Clinical Project Services, MPS Research Unit

    4. Oversight

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastric Cancer
    Keywords
    Gastric Cancer, G17DT, PAS, Insegia, Gastrimmune

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    10µg, Stage I-III
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    100µg, Stage I-III
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    250µg, Stage I-III
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    100µg, Stage IV
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    250µg, Stage IV
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    G17DT
    Other Intervention Name(s)
    Gastrimmune, Insegia, PAS
    Primary Outcome Measure Information:
    Title
    Measurable Antibody Titer
    Time Frame
    Up to Week 12
    Secondary Outcome Measure Information:
    Title
    Overall Survival from date of randomization to death or end of study
    Description
    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.
    Time Frame
    Up to Last Patient Last Visit, January 2001
    Title
    Injection Site Reaction
    Description
    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.
    Time Frame
    Through Week 12

    10. Eligibility

    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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