Glioblastoma, Neuroblastoma, Sarcoma
Conditions
Keywords
NDV, Metastatic, Refractory, Cancer, Progression-free, survival, recurrent
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.
Interventions
BIOLOGICALNew 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.
Sponsors
Hadassah Medical Organization
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | at least 1 year | Measure progression-free survival of patients receiving New Castle Virus |
Countries
Israel
Outcome results
None listed