A Study to Test the Effectiveness of Virulizin® Given in Combination With Standard Chemotherapy for Pancreatic Cancer - Full Text View

Sponsored by:	Lorus Therapeutics
Information provided by:	Lorus Therapeutics
ClinicalTrials.gov Identifier:	NCT00040092

Purpose

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.

Condition	Intervention	Phase
Pancreatic Cancer	Drug: Virulizin®	Phase III

MedlinePlus related topics: Cancer Pancreatic Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Further study details as provided by Lorus Therapeutics:

Estimated Enrollment:	400
Study Start Date:	July 2002
Primary Completion Date:	July 2005 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications:

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.

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.

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.

Study ID Numbers:	LOR/VIR/P03/002
Study First Received:	June 19, 2002
Last Updated:	January 4, 2008
ClinicalTrials.gov Identifier:	NCT00040092 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Lorus Therapeutics:

Virulizin
Immunotherapy
Pancreas
Pancreatic Cancer
clinical trial

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases

Gastrointestinal Neoplasms
Endocrinopathy
Pancrelipase
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms

Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009