Know Cancer

or
forgot password

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


Phase 1/Phase 2
3 Years
75 Years
Not Enrolling
Both
Glioblastoma, Sarcoma, Neuroblastoma

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-free survival

Outcome Description:

Measure progression-free survival of patients receiving New Castle Virus

Outcome Time Frame:

at least 1 year

Safety Issue:

No

Principal Investigator

Reuven Or, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hadassah Medical Organization

Authority:

Israel: Ministry of Health

Study ID:

NDV-HUJ-HMO-CTIL

NCT ID:

NCT01174537

Start Date:

September 2010

Completion Date:

September 2014

Related Keywords:

  • Glioblastoma
  • Sarcoma
  • Neuroblastoma
  • NDV
  • Metastatic
  • Refractory
  • Cancer
  • Progression-free
  • survival
  • recurrent
  • Glioblastoma
  • Neuroblastoma
  • Sarcoma

Name

Location