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

Gastric Cancer Clinical Trial

— GC5  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02450032
• Other study ID #: GC5
• Status: Completed
• Phase: Phase 2
• First received: August 27, 2014
• Last updated: May 20, 2015
• Start date: February 2000
• Est. completion date: May 2001

Study information

• Verified date: May 2015
• Source: Cancer Advances Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2001
• Est. primary completion date: May 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Biological:
• G17DT

Locations

Country	Name	City	State
United Kingdom	Glasgow Royal Infirmary	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Advances Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through Week 12	No
Primary	Injection Site Reaction	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.	Up to Week 12	Yes
Primary	Change in Subject's World Health Organization Performance Status	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.	Through Week 12	Yes
Secondary	Overall Survival	Vital status was monitored throughout the study. Patients were followed up to their death or the study completion date, 18 June 2001.	From date of randomization up to Week 24 or until death	No
Secondary	Adverse Events	All adverse events reported during the study.	Through week 12	Yes