Clinical trial · Interventional
A Study to Test the Effectiveness of Virulizin® Given in Combination With Standard Chemotherapy for Pancreatic Cancer
NCT00040092CI-TRIAL-00001088completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Virulizin® | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* 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
References
Publications (3)
- BACKGROUNDFerdinandi 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. PMID 11139822
- BACKGROUNDLiu 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. PMID 10762639
- BACKGROUNDWarner 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. PMID 8174313