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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Glioblastoma, Sarcoma, Neuroblastoma

Intervention / Treatment
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* Biological: New Castle Disease Virus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Measure progression-free survival of patients receiving New Castle Virus | at least 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NDV, Metastatic, Refractory, Cancer, Progression-free, survival, recurrent