Clinical trial · Interventional
New Castle Disease Virus (NDV) in Glioblastoma Multiforme (GBM), Sarcoma and Neuroblastoma
Clinical Application of Intravenous New Castle Disease Virus - HUJ Oncolytic Virus in the Treatment of Advanced Glioblastoma Multiforme, Soft and Bone Sarcomas and Neuroblastoma Patients, Resistant to Conventional Anti- Cancer Modalities
NCT01174537CI-TRIAL-00018240withdrawnPhase 1 / Phase 2ClinicalTrials.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)
Patients with specific metastatic cancers who failed prior therapeutic regimes will be treated with NDV for at least a year or until disease progression. The study will measure progression-free disease and posits that it will be extended.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| New Castle Disease Virus | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- at least 1 year
- description
- Measure progression-free survival of patients receiving New Castle Virus
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Evidence of progressive disease in the above categories evaluated by standard tumor staging. * Histologically confirmed diagnosis. * Failure of conventional anti- cancer modalities.despite optimal application of all relevant available anti- cancer modalities. * Age between 3 and 75 years old. * Liver function tests less than twice the normal, renal function no more than 20% reduction and white cell and platelets count no more than 30% reduction. * Karnofsky performance status of 50% or greater * A written informed consent understood and signed by the patient and by a spouse, parent or guardian. In patients with GBM two signs will be required due to possible alterations of psych and understanding. Exclusion Criteria: * Not fulfilling any of the above criteria * Moribund patients or patients with life- expectancy \< 3 months * Karnofksy performance status \< 50% * Pregnant or lactating women * Active local or systemic infections requiring treatment * Patients receiving other investigational agents * History of allergy to egg ova-albumin. * Co-morbidity or life- threatening clinical condition other than the basic cancer
References
Publications (8)
- BACKGROUNDGerl R, Vaux DL. Apoptosis in the development and treatment of cancer. Carcinogenesis. 2005 Feb;26(2):263-70. doi: 10.1093/carcin/bgh283. Epub 2004 Sep 16. PMID 15375012
- BACKGROUNDZitvogel L, Apetoh L, Ghiringhelli F, Kroemer G. Immunological aspects of cancer chemotherapy. Nat Rev Immunol. 2008 Jan;8(1):59-73. doi: 10.1038/nri2216. PMID 18097448
- BACKGROUNDRavindra PV, Tiwari AK, Sharma B, Chauhan RS. Newcastle disease virus as an oncolytic agent. Indian J Med Res. 2009 Nov;130(5):507-13. PMID 20090097
- BACKGROUNDVigil A, Park MS, Martinez O, Chua MA, Xiao S, Cros JF, Martinez-Sobrido L, Woo SL, Garcia-Sastre A. Use of reverse genetics to enhance the oncolytic properties of Newcastle disease virus. Cancer Res. 2007 Sep 1;67(17):8285-92. doi: 10.1158/0008-5472.CAN-07-1025. PMID 17804743
- BACKGROUNDFreeman AI, Zakay-Rones Z, Gomori JM, Linetsky E, Rasooly L, Greenbaum E, Rozenman-Yair S, Panet A, Libson E, Irving CS, Galun E, Siegal T. Phase I/II trial of intravenous NDV-HUJ oncolytic virus in recurrent glioblastoma multiforme. Mol Ther. 2006 Jan;13(1):221-8. doi: 10.1016/j.ymthe.2005.08.016. Epub 2005 Oct 28. PMID 16257582
- BACKGROUNDNelson NJ. Scientific interest in Newcastle disease virus is reviving. J Natl Cancer Inst. 1999 Oct 20;91(20):1708-10. doi: 10.1093/jnci/91.20.1708. No abstract available. PMID 10528013
- BACKGROUNDSchirrmacher V, Griesbach A, Ahlert T. Antitumor effects of Newcastle Disease Virus in vivo: local versus systemic effects. Int J Oncol. 2001 May;18(5):945-52. doi: 10.3892/ijo.18.5.945. PMID 11295039
- BACKGROUNDLowe SW, Lin AW. Apoptosis in cancer. Carcinogenesis. 2000 Mar;21(3):485-95. doi: 10.1093/carcin/21.3.485.