Sequential Trial Of G17DT For The Treatment Of Advanced Pancreatic Cancer

Study Overview

Sequential Trial of G17DT for the Treatment of Advanced Pancreatic Cancer

Compare the effect of G17DT with that of placebo on the survival of subjects with advanced pancreatic cancer.

N/A

Pancreatic Cancer

BIOLOGICAL: 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 2014-04-16	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2014-04-17
First Submitted that Met QC Criteria 2014-04-17	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2014-04-21
First Posted (ESTIMATED) 2014-04-21	Results First Posted N/A	Last Verified 2014-04

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:
Randomized

Interventional Model:
N/A

Masking:
Quadruple

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: G17DT 250 µg administered at Weeks 0,1,3 and 24 by intramuscular injection, followed by additional injections (boosters) of 250 µg every 6 months at investigator's discretion.	BIOLOGICAL: G17DT
PLACEBO_COMPARATOR: Placebo Placebo administered at Weeks 0, 1, 3, and 24 by intramuscular injection followed by additonal injections of placebo every 6 months.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: G17DT

250 µg administered at Weeks 0,1,3 and 24 by intramuscular injection, followed by additional injections (boosters) of 250 µg every 6 months at investigator's discretion.

BIOLOGICAL: G17DT

PLACEBO_COMPARATOR: Placebo

Placebo administered at Weeks 0, 1, 3, and 24 by intramuscular injection followed by additonal injections of placebo every 6 months.

Primary Outcome Measures	Measure Description	Time Frame
Patient Survival	The vital status of each patient was followed until death or end of the study.	Up to week 134
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 134

Secondary Outcome Measures	Measure Description	Time Frame
Objective tumor response	Patients were monitored for an objective tumor response measured by means of an abdomincal computed tomography.	Weeks 24 and 52

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:

Subjects with a histologically or cytologically confirmed diagnosis of pancreatic carcinoma, who were not eligible for tumor resection with curative intent (i.e., Stage II, III, or IV disease)
Male or female subjects over 18 years of age
Subjects with a life expectancy of at least 2 months
KPS score of ≥60%
Written informed consent

Previous, concomitant, or anticipated use (up to Week 12) of chemotherapy, radiotherapy, immunotherapy, or any other anticancer therapy
Previous (during the 4 weeks before the study), concomitant, or anticipated use (up to Week 12) of immunosuppressants. However, for systemic [i.e., oral or injected] corticosteroids, previous use and concomitant use at study entry were prohibited, while introduction during the course of the study was permitted.)
History of other malignant tumor within the previous 5 years, except nonmelanomatous skin cancer, and in situ carcinoma of the uterine cervix
Known immunodeficiency
Females who were pregnant, planning to become pregnant, or lactating (Women who, in the opinion of the investigator, were of childbearing potential were to have a negative pregnancy test before study drug administration.)
Subjects taking part in another study involving an investigational or licensed drug or device in the 3 months preceding enrollment or up to Week 12 during this study
Previous G17DT treatment
Hematological indicators as follows:

Hemoglobin <9.5 g/dL
Neutrophils <2.0 × 109/L
Platelets <100 × 109/L
Any other condition or circumstance that might have the following results:

Worsen if the subject participated in the study
Reduce the subject's ability to comply with the protocol
Confound the interpretation of the study results

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

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Clinical Trial Record