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Newcastle Disease Virus (NDV) for Cancer Patients Resistant to Conventional Anti-cancer Modalities

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00348842
Recruitment Status : Withdrawn
First Posted : July 6, 2006
Last Update Posted : April 8, 2011
Sponsor:
Information provided by:
Hadassah Medical Organization

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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



Primary Outcome Measures :
  1. Safety and primary efficacy of NDV treatment in cancer patients who failed conventional modalities.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with the following disease category will be eligible:

Patients with metastatic lung cancer, metastatic GI cancer, metastatic urogenital cancer, skin and soft tissue cancer.

  • Failure to anti-cancer modalties and evidence of progressive disease despite optimal application of all relevant available anti-cancer modalities.
  • Consenting patients.
  • The patient should sign a consent form stating that he/she will make sure to avoid any contact with chicken or any other species of birds.

Exclusion Criteria:

  • Not fulfilling any of the above criteria.
  • Moribund patients or patients with life-expectancy <3 months.
  • Karnofsky performance status <60%.
  • Pregnant or lactating women.
  • Active local or systemic infections requiring treatment.
  • Co-morbidity or life-threatening clinical condtion other than the basic cancer.

Information from the National Library of Medicine

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


Locations
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Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
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Principal Investigator: Shimon Slavin, MD Hadassah Medical Organization

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ClinicalTrials.gov Identifier: NCT00348842     History of Changes
Other Study ID Numbers: 397231205-HMO-CTIL
First Posted: July 6, 2006    Key Record Dates
Last Update Posted: April 8, 2011
Last Verified: February 2006
Keywords provided by Hadassah Medical Organization:
Immunotherapy
Additional relevant MeSH terms:
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Newcastle Disease
Virus Diseases
Avulavirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections