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

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ClinicalTrials.gov Identifier: NCT02233712
Recruitment Status : Completed
First Posted : September 8, 2014
Last Update Posted : September 8, 2014
Sponsor:
Information provided by (Responsible Party):
Cancer Advances Inc.

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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Biological: G17DT Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 1999
Actual Primary Completion Date : March 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Group 1
G17DT; 250 µg dose administered at 0, 1, and 3 weeks.
Biological: G17DT
Other Name: Polyclonal Antibody Stimulator (PAS)

Experimental: Group 2
G17DT; 100 µg dose administered at 0, 1, and 3 weeks.
Biological: G17DT
Other Name: Polyclonal Antibody Stimulator (PAS)

Experimental: Group 3
G17DT; 500 µg dose administered at 0, 1, and 3 weeks.
Biological: G17DT
Other Name: Polyclonal Antibody Stimulator (PAS)

Experimental: Group 4
G17DT; 500 µg dose administered at 0, 2, and 6 weeks.
Biological: G17DT
Other Name: Polyclonal Antibody Stimulator (PAS)




Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: Up to Week 24 ]
    Any adverse events that were reported during the study



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02233712


Sponsors and Collaborators
Cancer Advances Inc.
Investigators
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Principal Investigator: Peter G McCulloch, MB, ChB University Hospital Aintree

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Responsible Party: Cancer Advances Inc.
ClinicalTrials.gov Identifier: NCT02233712     History of Changes
Other Study ID Numbers: GC3
First Posted: September 8, 2014    Key Record Dates
Last Update Posted: September 8, 2014
Last Verified: September 2014

Keywords provided by Cancer Advances Inc.:
gastric cancer, stomach neoplasms,

Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antibodies
Immunoglobulins
Gastrins
Immunologic Factors
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists