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

Hadassah Medical Center

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

Glioblastoma

Neuroblastoma

Sarcoma

Treatments

Biological: New Castle Disease Virus

Study type

Interventional

Funder types

Other

Identifiers

NCT01174537

NDV-HUJ-HMO-CTIL

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

3 to 75 years old

Volunteers

No Healthy Volunteers

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