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

Pancreatic Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00040092
• Other study ID #: LOR/VIR/P03/002
• Status: Completed
• Phase: Phase 3
• First received: June 19, 2002
• Last updated: January 4, 2008
• Start date: July 2002

Study information

• Verified date: January 2008
• Source: Aptose Biosciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00045409

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Virulizin®

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aptose Biosciences Inc.

References & Publications (3)

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. — View 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. — View 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. — View Citation