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Completed

NCT Number: NCT02450032

Study to Determine the Antibody Response to 500µg G17DT in Treatment of Patients With Gastric Cancer

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

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Glasgow Royal Infirmary

Glasgow, G31 2 ER, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

G17DT

Biological

Other names: Polyclonal Antibody Stimulator

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Cancer Advances Inc.

Industry

Registry information

Official study 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

Acronym: GC5

Important dates

Study start
2000
Primary completion
2001
Study completion
2001
First posted
May 21, 2015
Registry last updated
May 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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