Clinical trial NCT01174537: 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
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Glioblastoma
Sarcoma
Neuroblastoma
Keywords: NDV
Metastatic
Refractory
Cancer
Progression-free
survival
recurrent
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2010-08-03
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Progression-free survival
timeFrame: at least 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Reuven Or, MD
role: PRINCIPAL_INVESTIGATOR
References:
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