New Castle Disease Virus (NDV) in Glioblastoma Multiforme (GBM), Sarcoma and Neuroblastoma - Full Text View

Sponsor:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT01174537

Purpose

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.

Condition	Intervention	Phase
Glioblastoma Sarcoma Neuroblastoma	Biological: New Castle Disease Virus	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Neuroblastoma Soft Tissue Sarcoma

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

Progression-free survival [ Time Frame: at least 1 year ] [ Designated as safety issue: No ]
Measure progression-free survival of patients receiving New Castle Virus

Estimated Enrollment:	30
Study Start Date:	September 2010
Estimated Study Completion Date:	September 2014
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	3 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01174537

Contacts

Contact: Reuven Or, MD	00 972 2 6776561	reuvenor@hadassah.org.il
Contact: Liliane Dray, BA	00 972 2 6777260	lilane@hadassah.org.il

Locations

Israel
Hadassah Medical Organization	Not yet recruiting
Jerusalem, Israel, 91120
Contact: Reuven Or, MD 00 972 2 6776561 reuvenor@hadassah.org.il
Contact: Liliane Dray, BA 00 972 2 6777260 lilane@hadassah.org.il

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Principal Investigator:

Reuven Or, MD

Hadassah Medical Organization

More Information

Publications:

Gerl R, Vaux DL. Apoptosis in the development and treatment of cancer. Carcinogenesis. 2005 Feb;26(2):263-70. Epub 2004 Sep 16. Review.

Zitvogel L, Apetoh L, Ghiringhelli F, Kroemer G. Immunological aspects of cancer chemotherapy. Nat Rev Immunol. 2008 Jan;8(1):59-73. Review.

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. Review.

Vigil A, Park MS, Martinez O, Chua MA, Xiao S, Cros JF, Martínez-Sobrido L, Woo SL, García-Sastre A. Use of reverse genetics to enhance the oncolytic properties of Newcastle disease virus. Cancer Res. 2007 Sep 1;67(17):8285-92.

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. Epub 2005 Oct 28.

Nelson NJ. Scientific interest in Newcastle disease virus is reviving. J Natl Cancer Inst. 1999 Oct 20;91(20):1708-10. No abstract available.

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.

Lowe SW, Lin AW. Apoptosis in cancer. Carcinogenesis. 2000 Mar;21(3):485-95. Review.

Responsible Party:	ReuvenOr, Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT01174537 History of Changes
Other Study ID Numbers:	NDV-HUJ-HMO-CTIL
Study First Received:	August 2, 2010
Last Updated:	August 2, 2010
Health Authority:	Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:

NDV
Metastatic
Refractory
Cancer

Progression-free
survival
recurrent

Additional relevant MeSH terms:

Glioblastoma
Neuroblastoma
Sarcoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Connective and Soft Tissue

ClinicalTrials.gov processed this record on May 23, 2012