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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.
Present therapeutic regimes have not much improved the survival of patients with metastatic cancer. Therapeutic cancer vaccines are a form of immunotherapy designed to educate the immune system to recognise tumor cells as foreign rather than self. New Castle Virus (NDV) has a long history as a broad system oncolytic that can destroy tumor cells and stimulate the immune system. Up to 30 patients suffering from recurrent, refractory Glioblastoma Multiforme, soft an bone sarcomas and disseminated neuroblastoma will be enrolled in this trial and receive daily doses of NDV at least 5 days a week for a minimum of a year or until disease progression.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New Castle Disease Virus | Biological | Patients will receive IV 1*10^10 EID50 (50 percent Embryo Infectious Dose. One EID50 unit is the amount of virus that will infect 50 percent of inoculated eggs) on a daily basis for a minimum of 5 days a week until disease progression for a minimum duration of 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Measure progression-free survival of patients receiving New Castle Virus | at least 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Reuven Or, MD | Hadassah Medical Organization | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Medical Organization | Jerusalem | 91120 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15375012 | Background | Gerl 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. | |
| 18097448 | Background | Zitvogel 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. |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D012509 | Sarcoma |
| D009447 | Neuroblastoma |
| D009362 | Neoplasm Metastasis |
| D009369 | Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| 20090097 | Background | Ravindra PV, Tiwari AK, Sharma B, Chauhan RS. Newcastle disease virus as an oncolytic agent. Indian J Med Res. 2009 Nov;130(5):507-13. |
| 17804743 | Background | Vigil 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. |
| 16257582 | Background | Freeman 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. |
| 10528013 | Background | Nelson 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. |
| 11295039 | Background | Schirrmacher 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. |
| 10688869 | Background | Lowe SW, Lin AW. Apoptosis in cancer. Carcinogenesis. 2000 Mar;21(3):485-95. doi: 10.1093/carcin/21.3.485. |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |