Newcastle Disease Virus (NDV) for Cancer Patients Resistant to Conventional Anti-cancer Modalities
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|ClinicalTrials.gov Identifier: NCT00348842|
Recruitment Status : Withdrawn
First Posted : July 6, 2006
Last Update Posted : April 8, 2011
NDV is a virus tht is harmful in chicken, but harmless in man. There are 2 major sub-strains of NDV, one oncolytic and one non-oncolytic. Oncolytic NDV (MTH-68H) preferentially homes and replicates in cancer cells and therefore, administration of NDV intravenously or preferentially intra-tumor, either by direct injection or by injection into an afferent artery results in direct lysis of tumor cells. NDV activates apoptotic mechanism in cancer cells and thus, results in natural cell death.
Both oncolytic and non-oncolytic NDV were used clinically in hundreds of patients with different types of cancer worldwide. NDV were proved harmless in man. Clinical studies were done for more than a decade and the efficacy of NDV was documented on pre-clinical animals models as well as in man.
For a large number of patients with metastatic cancer and chemotherapy resistant hematological malignances, no cure can be provided by conventional anti-cancer modalities, new treatment options are urgently indicated. The goal of the study is to use NDV, in order to provide such treatment for patients in need.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cancer Newcastle Disease Virus (NDV)||Procedure: Newcastle Virus||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II: Safety and Primary Efficacy of Clinical Application of Newcastle Disease Virus for the Treatment of Patients Resistant to All Conventional Modalities|
|Study Start Date :||March 2006|
|Estimated Study Completion Date :||June 2006|
- Safety and primary efficacy of NDV treatment in cancer patients who failed conventional modalities.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00348842
|Hadassah Medical Organization|
|Jerusalem, Israel, 91120|
|Principal Investigator:||Shimon Slavin, MD||Hadassah Medical Organization|