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

Metastatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00348842
• Other study ID #: 397231205-HMO-CTIL
• Status: Withdrawn
• Phase: Phase 2
• First received: July 4, 2006
• Last updated: April 7, 2011
• Start date: March 2006
• Est. completion date: June 2006

Study information

• Verified date: February 2006
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis
• Newcastle Disease Virus (NDV)

Intervention

Procedure:
• Newcastle Virus

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and primary efficacy of NDV treatment in cancer patients who failed conventional modalities.