Safety and Effectiveness Study of Autologous Natural Killer and Natural Killer T Cells on Cancer
NCT00909558 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2010-02-24
Summary
The purpose of this study is to assess the safety and effectiveness of natural killer (NK) cell and natural killer T (NKT) cell-based autologous adoptive immunotherapy in subjects with metastatic, treatment-refractory breast cancer, glioma, hepatocellular carcinoma, squamous cell lung cancer, pancreatic cancer, colon cancer or prostate cancer.
Conditions
- Breast Cancer
- Glioma
- Hepatocellular Cancer
- Squamous Cell Lung Cancer
- Pancreatic Cancer
- Colon Cancer
- Prostate Cancer
Interventions
- BIOLOGICAL
-
Autologous Natural Killer / Natural Killer T Cell Immunotherapy
The study drug is derived from ex vivo expansion of each subject's own white blood cells and is therefore autologous. The current study proposes a 3-course treatment of doses administered at one week intervals with monitoring at each administration plus 2 weeks after the last dose. The total study time (apheresis through last follow-up) is estimated at 15 weeks.
Sponsors & Collaborators
-
Envita Medical Center, Inc.
lead INDUSTRY
Principal Investigators
-
David Korn, D.O., M.D. · Envita Medical Centers
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-05-31
- Primary Completion
- 2010-06-30
Countries
- United States
Study Locations
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