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Trial record 1 of 5 for:    Polyclonal Antibody Stimulator
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Study to Determine the Antibody Response to 500µg G17DT in Treatment of Patients With Gastric Cancer (GC5)

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ClinicalTrials.gov Identifier: NCT02450032
Recruitment Status : Completed
First Posted : May 21, 2015
Last Update Posted : May 21, 2015
Sponsor:
Information provided by (Responsible Party):
Cancer Advances Inc.

Brief Summary:
This study was designed to investigate the antibody response generated by a 500µg dose of G17DT in patients with gastric cancer.

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

Detailed Description:
Another study, GC2, initiated prior to the start of this study investigated the appropriate dose and dosing schedule for G17DT in patients with Stage I-III gastric cancer. The highest dose tested in the GC2 study was 250µg. This dose was well tolerated but was not considered sufficiently immunogenic. Since tolerability had not constrained dosing up to 250µg, the GC5 study was designed to investigate a 500µg dose administered as a regimen of 0, 2, and 6 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open, Multi-center Study to Determine the Antibody Response to 500µg G17DT Given at Weeks 0, 2, and 6 in the Treatment of Patients With Gastric Cancer
Study Start Date : February 2000
Actual Primary Completion Date : May 2001
Actual Study Completion Date : May 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: G17DT
Treatment with 500µg/ 0.4mL dose of G17DT administered by intramuscular injection at 0, 2, and 6 weeks.
Biological: G17DT
Other Name: Polyclonal Antibody Stimulator




Primary Outcome Measures :
  1. Antibody Levels [ Time Frame: Through Week 12 ]
    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 ]
    A physical examination for the presence of an abscess at the injection site was performed on each patient to assess tolerability to treatment at every posttreatment visit from Week 0 to Week 12.

  3. Change in Subject's World Health Organization Performance Status [ Time Frame: Through Week 12 ]
    The subject's WHO performance status was evaluated at each visit up to Week 12 to assess changes in subject's ability complete normal daily activities.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: From date of randomization up to Week 24 or until death ]
    Vital status was monitored throughout the study. Patients were followed up to their death or the study completion date, 18 June 2001.

  2. Adverse Events [ Time Frame: Through week 12 ]
    All adverse events reported during the study.



Information from the National Library of Medicine

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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:

  • Patients with histologically confirmed UICC Stage I, II or III gastric adenocarcinoma.
  • Patients 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 patients aged 18 years or older.
  • Life expectancy of at least 3 months.
  • WHO Performance Status of 0 to 1.
  • Written informed consent

Exclusion Criteria:

  • Gastric surgery within four weeks of baseline (Week 0, visit 2) or gastric surgery anticipated during the period of the study.
  • History of other malignant disease within the previous five years, except nonmelanomatous skin cancer or in situ carcinoma of the uterine cervix.
  • Previous use within the last four weeks, concomitant use of anticipated use in the period of study, of any anti-cancer therapies.
  • Concomitant use of immunosuppressants, including systemic (i.e. oral or injected) corticosteroids.
  • Females who were pregnant, planning to become pregnant or lactating.
  • Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrollment or during this study.
  • Previous G17DT treatment.
  • Haematologicial indicators:

Haemoglobin (Hb) < 10g/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): NCT02450032


Locations
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United Kingdom
Glasgow Royal Infirmary
Glasgow, United Kingdom, G31 2 ER
Sponsors and Collaborators
Cancer Advances Inc.
Investigators
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Principal Investigator: Robert Stuart, MB ChB Glasgow Royal Infirmary

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Responsible Party: Cancer Advances Inc.
ClinicalTrials.gov Identifier: NCT02450032    
Other Study ID Numbers: GC5
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Antibodies
Immunoglobulins
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Gastrins
Immunologic Factors
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists