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NCT00283075 · ClinicalTrials.gov registry record · Phase 1
Mouse Cancer Cell-containing Macrobeads in the Treatment of Human Cancer
A Phase 1 study, sponsored by The Rogosin Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT00283075: Completed Phase 1 study, sponsored by The Rogosin Institute.
NCT00283075 is a Phase 1 study that has completed, run by The Rogosin Institute. The registered enrollment target is 56 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00283075, a Phase 1 study, has completed, sponsored by The Rogosin Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
Study 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.
Primary Outcome
Dose limiting toxicity (DLT) was defined as: * any Grade 2 allergic reaction of generalized urticaria or any other Grade ≥ 3 allergic reaction; * any Grade ≥ 3 infection and * any Grade ≥ 3 local (intraperitoneal) reaction and any Grade ≥ 3 hematologic or non- hematologic reaction. This definition of DLT is in accord with the NCI CTCAE v3.0. Maximum tolerated dose (MTD) was to be identified if, within a cohort, \> 1 subject out of the first 3, or 2 subjects out of 5 experienced DLT. In such a
Interventions
- BIOLOGICAL Cancer Macrobead placement in abdominal cavity
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2005-01 |
| Est. Completion | 2015-02 |
| Phase | Phase 1 |
What the finished NCT00283075 record still lists
NCT00283075 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Cancer Macrobead placement in abdominal cavity is the first listed.
NCT00283075 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00283075 about?
NCT00283075 is a clinical study titled "Mouse Cancer Cell-containing Macrobeads in the Treatment of Human Cancer". 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 tes...
What is the current status of trial NCT00283075?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2005-01. Estimated completion is 2015-02.
What interventions are being tested in trial NCT00283075?
The interventions under investigation include: Cancer Macrobead placement in abdominal cavity (BIOLOGICAL).
Who is sponsoring clinical trial NCT00283075?
This trial is sponsored by The Rogosin Institute, which has 21 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00283075's enrollment target sits among peer trials
56 902nd of 2000 higher than 1,083 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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