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

Phase 1

Withdrawn

• Conditions: Glioblastoma; Sarcoma; Neuroblastoma

• Registration Number: NCT01174537
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2010-08
• Study First Submitted: 2010-08-02
• Study First Submitted QC: 2010-08-02
• Study First Posted: 2010-08-03
• Study Start: 2011-07
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Last Update Submitted: 2015-06-10
• Last Update Posted: 2015-06-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Progression-free survival	at least 1 year	Measure progression-free survival of patients receiving New Castle Virus

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel