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

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ClinicalTrials.gov Identifier: NCT01174537
Recruitment Status : Withdrawn
First Posted : August 3, 2010
Last Update Posted : June 11, 2015
Information provided by:
Hadassah Medical Organization

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.

Condition or disease Intervention/treatment Phase
Glioblastoma Sarcoma Neuroblastoma Biological: New Castle Disease Virus Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2011
Primary Completion Date : July 2011
Study Completion Date : July 2011

Intervention Details:
    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.

Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: at least 1 year ]
    Measure progression-free survival of patients receiving New Castle Virus

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01174537

Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Reuven Or, MD Hadassah Medical Organization

Responsible Party: ReuvenOr, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01174537     History of Changes
Other Study ID Numbers: NDV-HUJ-HMO-CTIL
First Posted: August 3, 2010    Key Record Dates
Last Update Posted: June 11, 2015
Last Verified: August 2010

Keywords provided by Hadassah Medical Organization:

Additional relevant MeSH terms:
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive