Phase II: Safety and Primary Efficacy of Clinical Application of Newcastle Disease Virus for the Treatment of Patients Resistant to All Conventional Modalities
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- Safety and primary efficacy of NDV treatment in cancer patients who failed conventional modalities.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Safety and primary efficacy of NDV treatment in cancer patients who failed conventional modalities.
Secondary Outcomes
No secondary outcomes reported