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

This study is currently recruiting participants.
Verified by Hadassah Medical Organization, February 2006

Sponsored by: Hadassah Medical Organization
Information provided by: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00348842
  Purpose

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   

U.S. FDA Resources

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

Further study details as provided by Hadassah Medical Organization:

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

Study Start Date:   March 2006
Estimated Study Completion Date:   June 2006

  Eligibility
Genders Eligible for Study:   Both
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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00348842

Contacts
Contact: Shimon Slavin, MD     +972-2-6776561     slavin@cc.huji.ac.il    
Contact: Hadas Lemberg, phD     +972-2-6777572     lhadas@hadassah.org.il    

Locations
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            

Sponsors and Collaborators
Hadassah Medical Organization

Investigators
Principal Investigator:     Shimon Slavin, MD     Hadassah Medical Organization    
  More Information


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

Keywords provided by Hadassah Medical Organization:
Immunotherapy  

Study placed in the following topic categories:
Virus Diseases
Paramyxoviridae Infections
Neoplasm Metastasis
Newcastle Disease

Additional relevant MeSH terms:
RNA Virus Infections
Neoplasms
Neoplastic Processes
Pathologic Processes
Avulavirus Infections
Mononegavirales Infections

ClinicalTrials.gov processed this record on October 10, 2008




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