Mouse Cancer Cell-containing Macrobeads in the Treatment of Human Cancer
NCT00283075 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56
Last updated 2019-01-16
Summary
This is a phase 1 trial to evaluate the safety and toxicity of mouse kidney cancer cell-containing agarose-agarose macrobeads that are implanted in the abdominal cavity as a proposed biological treatment of patients with end-stage, treatment-resistant cancer. The macrobeads have been extensively tested in tumor models in mice and rats, as well as in forty-five veterinary patients (cats and dogs) with naturally occurring tumors of various types including breast cancer, prostate cancer, liver cancer, and lymphoma with clear tumor responses and no significant detectable toxicity.
Conditions
- Intraabdominal Cancers (Various Types)
Interventions
- BIOLOGICAL
-
Cancer Macrobead placement in abdominal cavity
8 macrobeads per kg
Sponsors & Collaborators
-
The Rogosin Institute
lead OTHER
Principal Investigators
-
Barry H Smith, MD, PhD · The Rogosin Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-01-31
- Primary Completion
- 2012-12-31
- Completion
- 2015-02-28
Countries
- United States
Study Locations
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