Single Centre Study To Determine The Antibody Response To G17DT In Patients With Advanced Pancreatic Cancer.

Study Overview

Single Centre Study to Determine the Antibody Response to G17DT in Patients With Advanced Pancreatic Cancer.

The study was designed to assess the effect of jaundice on the ability of G17DT to generate antibodies before and after treatment of biliary obstruction due to advances pancreatic cancer.

Jaundiced patients with advanced pancreatic cancer (either locally, advanced or metastatic) were treated with G17DT either immediately (Group A), or following biliary stenting when jaundice had resolved (Group B). Patients not jaundiced at time of presentation were to enter Group B. Patients received 3 Intramuscular injections of G17DT at weeks 0, 1, and 3. A booster injection was offered to patients who had measurable anit-G17Dt antibodies but had anti-G17DT antibodies that fell below a pre-specified threshold after week 23. Patients were evaluated until study closure ort until patient death.

Jaundice
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 2014-03-25	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2014-03-25
First Submitted that Met QC Criteria 2014-03-25	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2014-03-27
First Posted (ESTIMATED) 2014-03-27	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:
Non Randomized

Interventional Model:
N/A

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Group A Jaundiced patients with bilirubin value >80 μmol/L. Received G17DT immediately prior to biliary stenting.	DRUG: G17DT
ACTIVE_COMPARATOR: Group B Patients to be treated following biliary decompression or for immediate treatment if non-jaundiced. Received G17DT 2 weeks after biliary stenting when bilirubin was <40 μmol/L.	DRUG: G17DT

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: Group A

Jaundiced patients with bilirubin value >80 μmol/L. Received G17DT immediately prior to biliary stenting.

DRUG: G17DT

ACTIVE_COMPARATOR: Group B

Patients to be treated following biliary decompression or for immediate treatment if non-jaundiced. Received G17DT 2 weeks after biliary stenting when bilirubin was <40 μmol/L.

DRUG: G17DT

Primary Outcome Measures	Measure Description	Time Frame
Pharmacodynamic	Gastrin-17 antibodies were measured at baseline (Week 0) and measured at each post-treatment visit.	Weeks 0, 1,3,4,6,8,12, 16+
Patient Survival	The vital status of patients was monitored throughout the study and was followed until death or the end of the study.	Up to week 139

Secondary Outcome Measures	Measure Description	Time Frame
Injection Tolerability	Tolerability was assessed by injection site during first 16 weeks after the first injection.	Up to Week 16

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 a pancreatic adenocarcinoma (cytologically or histologically proven), not suitable for a potentially curative resection.
If patients were jaundiced, bilirubin had to be >80 μmol/L.
Male or female patients over 18 years of age.
World Health Organization (WHO) performance status of 0 to 2.
Patients with a life expectancy of at least 8 weeks.
Patients must have given written informed consent.

Patients undergoing a potentially curative resection.
Jaundiced patients with a bilirubin value <80 μmol/L.
Patients not considered fit for endoscopic or percutaneous biliary stenting.
Patients receiving any other anti-cancer therapy.
History of other malignant disease except non-melanomatous skin cancer or in situ carcinoma of the cervix.
Females who were pregnant, planning to become pregnant, or who were lactating.
Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during this study.
Previous G17DT treatment.
Haematological indicators:

Collaborators and Investigators

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

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record