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Phase II: Safety and Primary Efficacy of Clinical Application of Newcastle Disease Virus for the Treatment of Patients Resistant to All Conventional Modalities


Phase 2
N/A
N/A
Not Enrolling
Both
Metastatic Cancer, Newcastle Disease Virus (NDV)

Thank you

Trial Information

Phase II: Safety and Primary Efficacy of Clinical Application of Newcastle Disease Virus for the Treatment of Patients Resistant to All Conventional Modalities


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety and primary efficacy of NDV treatment in cancer patients who failed conventional modalities.

Principal Investigator

Shimon Slavin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hadassah Medical Organization

Authority:

Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:

397231205-HMO-CTIL

NCT ID:

NCT00348842

Start Date:

March 2006

Completion Date:

June 2006

Related Keywords:

  • Metastatic Cancer
  • Newcastle Disease Virus (NDV)
  • Immunotherapy
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Newcastle Disease
  • Virus Diseases

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