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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00040092

Enrollment

400

Registered

2002-06-20

Start date

2002-07-31

Completion date

Unknown

Last updated

2008-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

Virulizin, Immunotherapy, Pancreas, Pancreatic Cancer, clinical trial

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.

Interventions

DRUGVirulizin®

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026