Back to resultsA Study to Test the Effectiveness of Virulizin® Given in Combination With Standard Chemotherapy for Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Virulizin®
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring Virulizin, Immunotherapy, Pancreas, Pancreatic Cancer, clinical trial
Eligibility Criteria
Patients with advanced (unresectable or metastatic) pancreatic adenocarcinoma (TNM stages II, III or IV) No previous systemic chemotherapy(unless given as a radiosensitizer). ECOG Performance Status 0-2 Life expectancy equal to or greater than 12 weeks Adequate laboratory and organ functions Stabilizable pain (stable analgesic intake) No radiotherapy during 4 weeks prior to trial entry No evidence of ascites, pleural effusion or third space fluid accumulation Not currently using, and have not used in 4 weeks prior to entering trial, systemic steroids or hormonal therapy
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00040092
Brief Title
A Study to Test the Effectiveness of Virulizin® Given in Combination With Standard Chemotherapy for Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Aptose Biosciences Inc.
4. Oversight
5. Study Description
Brief Summary
Virulizin is an immunotherapy drug preparation that is thought to stimulate the patient's immune system, which in turn may slow the growth of tumors. It is presented in vials as a sterile preparation for IM injection. The purpose of the trial is to investigate if Virulizin in combination with gemcitabine provides better efficacy than gemcitabine alone (with placebo) against pancreatic cancer.Virulizin® efficacy will continue to be assessed if chemotherapy is changed to 5-Fluorouracil.
Detailed Description
A Phase III, Double-blind, Multicenter, Randomized Study in Chemonaive Patients with Locally Advanced or Metastatic Pancreatic Cancer to Compare a Combination Therapy of Virulizin® plus Gemcitabine versus Placebo plus Gemcitabine; Optional Secondline Therapy may Include Continuation of Virulizin® or Placebo, Alone or in Combination with 5-Fluorouracil.
Patients who have not received any prior chemotherapy will be randomized to receive Gemcitabine plus Virulizin® versus Gemcitabine plus placebo in a double blind fashion. On disease progression patients may be switched to 5-Fluorouracil and continue to receive Virulizin® or placebo. Patients may continue Virulizin® alone, if clinically indicated when 5-Fluorouracil is discontinued.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Virulizin, Immunotherapy, Pancreas, Pancreatic Cancer, clinical trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
400 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Virulizin®
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients with advanced (unresectable or metastatic) pancreatic adenocarcinoma (TNM stages II, III or IV)
No previous systemic chemotherapy(unless given as a radiosensitizer).
ECOG Performance Status 0-2
Life expectancy equal to or greater than 12 weeks
Adequate laboratory and organ functions
Stabilizable pain (stable analgesic intake)
No radiotherapy during 4 weeks prior to trial entry
No evidence of ascites, pleural effusion or third space fluid accumulation
Not currently using, and have not used in 4 weeks prior to entering trial, systemic steroids or hormonal therapy
12. IPD Sharing Statement
Citations:
PubMed Identifier
11139822
Citation
Ferdinandi ES, Braun DP, Liu C, Zee BC, Ely G. Virulizin(R) - A review of its antineoplastic activity. Expert Opin Investig Drugs. 1999 Oct;8(10):1721-1735. doi: 10.1517/13543784.8.10.1721.
Results Reference
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PubMed Identifier
10762639
Citation
Liu C, Ferdinandi ES, Ely G, Joshi SS. Virulizin-2gamma, a novel immunotherapeutic agent, in treatment of human pancreatic cancer xenografts. Int J Oncol. 2000 May;16(5):1015-20. doi: 10.3892/ijo.16.5.1015.
Results Reference
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PubMed Identifier
8174313
Citation
Warner E, Weinroth J, Chang S, MacDonald M, Strauss B. Phase II trial of Virulizin in patients with pancreatic cancer. Clin Invest Med. 1994 Feb;17(1):37-41.
Results Reference
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A Study to Test the Effectiveness of Virulizin® Given in Combination With Standard Chemotherapy for Pancreatic Cancer
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