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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 3 Years - 75 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01174537
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Hadassah Medical Organization
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Reuven Or, MD
Principal Investigator Affiliation Hadassah Medical Organization
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Withdrawn
Countries Israel
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma, Sarcoma, Neuroblastoma
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hadassah Medical Organization, Jerusalem, Israel

Status

Address

Hadassah Medical Organization

Jerusalem, , 91120

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