Back to results

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

Primary Purpose

Glioblastoma, Sarcoma, Neuroblastoma

Status

Withdrawn

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

New Castle Disease Virus

About this trial

This is an interventional treatment trial for Glioblastoma focused on measuring NDV, Metastatic, Refractory, Cancer, Progression-free, survival, recurrent

Eligibility Criteria

3 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hadassah Medical Organization

Outcomes

Primary Outcome Measures

Progression-free survival

Measure progression-free survival of patients receiving New Castle Virus

Secondary Outcome Measures

Full Information

NCT ID

NCT01174537

First Posted

August 2, 2010

Last Updated

June 10, 2015

Sponsor

Hadassah Medical Organization

1. Study Identification

Unique Protocol Identification Number

NCT01174537

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2010

Overall Recruitment Status

Withdrawn

Study Start Date

July 2011 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Hadassah Medical Organization

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma, Sarcoma, Neuroblastoma

Keywords

NDV, Metastatic, Refractory, Cancer, Progression-free, survival, recurrent

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

New Castle Disease Virus

Intervention Description

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.

Primary Outcome Measure Information:

Title

Progression-free survival

Description

Measure progression-free survival of patients receiving New Castle Virus

Time Frame

at least 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Reuven Or, MD

Organizational Affiliation

Hadassah Medical Organization

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hadassah Medical Organization

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

12. IPD Sharing Statement

Citations:

PubMed Identifier

15375012

Citation

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.

Results Reference

background

PubMed Identifier

18097448

Citation

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.

Results Reference

background

PubMed Identifier

20090097

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.

Results Reference

background

PubMed Identifier

17804743

Citation

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.

Results Reference

background

PubMed Identifier

16257582

Citation

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.

Results Reference

background

PubMed Identifier

10528013

Citation

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.

Results Reference

background

PubMed Identifier

11295039

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. doi: 10.3892/ijo.18.5.945.

Results Reference

background

PubMed Identifier

10688869

Citation

Lowe SW, Lin AW. Apoptosis in cancer. Carcinogenesis. 2000 Mar;21(3):485-95. doi: 10.1093/carcin/21.3.485.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs