Trial | NCT02233712  Report issue

Title

Open-label, Dose-finding Study to Determine Antibody Response to G17DT Treatment in Patients With Gastric Cancer.
An Open-label, Dose-finding, Schedule-changing, Multi-center Study to Determine the Antibody Response to G17DT Treatment of Patients With Gastric Cancer.

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    33
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.
Study Started
Aug 31
1999
Primary Completion
Mar 31
2000
Last Update
Sep 08
2014
Estimate

Biological G17DT

  • Other names: Polyclonal Antibody Stimulator (PAS)

Group 1 Experimental

G17DT; 250 µg dose administered at 0, 1, and 3 weeks.

Group 2 Experimental

G17DT; 100 µg dose administered at 0, 1, and 3 weeks.

Group 3 Experimental

G17DT; 500 µg dose administered at 0, 1, and 3 weeks.

Group 4 Experimental

G17DT; 500 µg dose administered at 0, 2, and 6 weeks.

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
No Results Posted