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

Gastric Cancer Clinical Trial

— GC3  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02233712
• Other study ID #: GC3
• Status: Completed
• Phase: Phase 2
• First received: August 27, 2014
• Last updated: September 5, 2014
• Start date: August 1999

Study information

• Verified date: September 2014
• 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. primary completion date: March 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, 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
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Advances Inc.

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.	Up to Week 24	No
Primary	Injection Site Reaction	An examination was performed to assess injection site tolerability at every posttreatment visit from Week 1 to Week 12 (end of core phase).	Up to Week 12	Yes
Primary	World Health Organization (WHO) Performance Status	WHO performance status was monitored up to Week 12 to compare final status with baseline status.	Up to Week 12	Yes
Primary	Diptheria Toxoid Antibody Levels	Diptheria toxoid antibody levels were measured at screening and at Week 12 to assess toxicity from Diptheria toxoid.	Up to Week 12	Yes
Secondary	Adverse Events	Any adverse events that were reported during the study	Up to Week 24	Yes