New Castle Disease Virus (NDV) in Glioblastoma Multiforme (GBM), Sarcoma and Neuroblastoma

Glioblastoma Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01174537
• Other study ID #: NDV-HUJ-HMO-CTIL
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: August 2, 2010
• Last updated: June 10, 2015
• Start date: July 2011
• Est. completion date: July 2011

Study information

• Verified date: August 2010
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioblastoma
• Neuroblastoma
• Sarcoma

Intervention

Biological:
• New Castle Disease Virus
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.

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (8)

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. — View Citation

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

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

Nelson NJ. Scientific interest in Newcastle disease virus is reviving. J Natl Cancer Inst. 1999 Oct 20;91(20):1708-10. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	Measure progression-free survival of patients receiving New Castle Virus	at least 1 year	No