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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01174537
First received: August 2, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted

August 2, 2010
August 2, 2010
September 2010
September 2013   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: at least 1 year ] [ Designated as safety issue: No ]
Measure progression-free survival of patients receiving New Castle Virus
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Glioblastoma
  • Sarcoma
  • Neuroblastoma
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
September 2014
September 2013   (final data collection date for primary outcome measure)

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
Both
3 Years to 75 Years
No
Contact: Reuven Or, MD 00 972 2 6776561 reuvenor@hadassah.org.il
Contact: Liliane Dray, BA 00 972 2 6777260 lilane@hadassah.org.il
Israel
 
NCT01174537
NDV-HUJ-HMO-CTIL
No
ReuvenOr, Hadassah Medical Organization
Hadassah Medical Organization
Not Provided
Principal Investigator: Reuven Or, MD Hadassah Medical Organization
Hadassah Medical Organization
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP