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Sponsored by: |
Hadassah Medical Organization |
Information provided by: | Hadassah Medical Organization |
ClinicalTrials.gov Identifier: | NCT00348842 |
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 | Intervention | Phase |
Metastatic Cancer Newcastle Disease Virus (NDV) |
Procedure: Newcastle Virus |
Phase II |
MedlinePlus related topics: | Cancer |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with metastatic lung cancer, metastatic GI cancer, metastatic urogenital cancer, skin and soft tissue cancer.
Exclusion Criteria:
Contact: Shimon Slavin, MD | +972-2-6776561 | slavin@cc.huji.ac.il |
Contact: Hadas Lemberg, phD | +972-2-6777572 | lhadas@hadassah.org.il |
Israel | |||||
Hadassah Medical Organization | Recruiting | ||||
Jerusalem, Israel, 91120 | |||||
Contact: Arik Tzukert, DMD +972-2-6776095 arik@hadassah.org.il | |||||
Contact: Hadas Lemberg, PhD +972-2-6777572 lhadas@hadassah.org.il | |||||
Sub-Investigator: Reuven Or, MD |
Hadassah Medical Organization |
Principal Investigator: | Shimon Slavin, MD | Hadassah Medical Organization |
Study ID Numbers: | 397231205-HMO-CTIL |
First Received: | July 4, 2006 |
Last Updated: | July 5, 2006 |
ClinicalTrials.gov Identifier: | NCT00348842 |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
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