An Open, Single-center Study To Determine The Antibody Repsonse To Gastrimmune And Its Safety And Tolerability In Patients With Advanced Pancreatic Carcinoma

Study Overview

An Open, Single-center Study to Determine the Antibody Repsonse to Gastrimmune and Its Safety and Tolerability in Patients With Advanced Pancreatic Carcinoma

This study was designed to determine the effect of jaundice on the ability of G17DT to generate antibodies before and after treatment of biliary obstruction due to advanced pancreatic cancer.

N/A

Pancreatic Cancer

DRUG: G17DT

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-03-12	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2014-03-26
First Submitted that Met QC Criteria 2014-03-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2014-03-28
First Posted (ESTIMATED) 2014-03-28	Results First Posted N/A	Last Verified 2014-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: G17DT	DRUG: G17DT

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: G17DT

DRUG: G17DT

Primary Outcome Measures	Measure Description	Time Frame
Pharmacodynamic	Anti-Gastrin 17 antibodies were determined at baseline (week0) and measured at subsequent visits during the first 16 weeks after the first G17DT injection to determine the effect of jaundice on the ability of patients to generate antibodies.	Up to week 16

Secondary Outcome Measures	Measure Description	Time Frame
Patient Survival	The vital status was monitored throughout the study and was followed up to the death of the last patient.	Up to week 139
Number of Participants with Serious and Non-Serious Adverse Events	Adverse events, defined as any event involving adverse reactions, illnesses with onset during the study, or exacerbations of pre-exisiting illnesses, were assessed at each visit.	Up to week 60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Patients with histological or cytological confirmation of pancreatic carcinoma who were not suitable for pancreatic tumour resection with curative intent
Patients who had not received chemotherapy in the previous month and who would either not receive chemotherapy in the period of study or who would commence gemcitabine treatment in week 4 of the study
Male or female patients over 18 years of age
Patients with a life expectancy of at least 2 months
Patients must have given written informed consent
Patients with a Karnofsky Performance Status score of ≥ 50%
Patients who would not receive chemotherapy in the period of the Extension Survival Study, except for concomitant gemcitabine ongoing at visit (for extension study)

History of other malignant disease except non-melanomatous skin carcinoma or in situ carcinoma of the uterine cervix
Concomitant use or anticipated use in the period of the study of radiotherapy
Chemotherapy in the previous month preceding screening, anticipated concomitant use of chemotherapy between screening and week 4 of the study or anticipated useof chemotherapeutic agents other than gemcitabine from week 4 for the period of the study
Use in the past month or 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 enrolment or during the study
Haematological indicators:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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General Publications

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