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NCT00325507 · ClinicalTrials.gov registry record · Phase 2
Safety and Biological Activity of TroVax® Vaccine Given With IL-2 in Renal Cell Carcinoma
A Phase 2 study of Carcinoma, Renal Cell, sponsored by Oxford BioMedica.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT00325507 is a Phase 2 study of Carcinoma, Renal Cell that has completed, run by Oxford BioMedica. The registered enrollment target is 25 participants, below the 283-participant average among 34 other Carcinoma, Renal Cell trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00325507, a Phase 2 study of Carcinoma, Renal Cell, has completed, sponsored by Oxford BioMedica.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to assess the safety and tolerability of TroVax® investigational vaccine injections when given as first or second line treatment in conjunction with subcutaneous low dose IL-2 to patients with locally advanced or metastatic clear cell or papillary cell renal carcinoma. TroVax® is the experimental product in this trial and its value as a medicine has not yet been proven. Interleukin-2 (IL-2) is a standard treatment for cancer, which means that it can be received even if one chooses not to participate in this study. TroVax® is being studied as a possible treatment for patients with cancer of the kidney. TroVax® belongs to a class of medicines called vaccines. A vaccine helps the body's immune system to recognize and kill foreign invading organisms effectively. It is believed that one of the reasons why cancer can spread through the body is that the immune system cannot recognize cancer cells as being different from normal tissues and therefore cannot kill the cancer cells. A vaccine that alerts the immune system to the presence of cancer cells in the body could lead to the immune system being able to target and kill those cancer cells effectively. This trial is of a completely new way of trying to treat cancer in the future by the use of vaccination injections. TroVax® consists of a virus that has been changed so that it is no longer infectious and carries a gene for a protein called 5T4. This protein is carried by many kidney cancer cells. When the virus is injected, it makes the protein, and the body's immune system is then able to recognize this protein and kill the cells that have it (i.e. the cancer cells). The purpose of this study is to assess the safety and tolerability of TroVax® injections and to understand whether TroVax® could make such an immune response happen in patients with renal cell cancer while receiving interleukin-2 (IL-2). This study will also observe and monitor any side effects experienced in patients who receiv
Conditions Studied
Interventions
- DRUG IL-2
- BIOLOGICAL TroVax
Study Locations (1)
Texas
- The Methodist Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2005-11 |
| Est. Completion | 2008-07 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00325507
The ClinicalTrials.gov registry entry for NCT00325507 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 283-participant average among 34 other Carcinoma, Renal Cell trials with a reported enrollment target (91% lower). The listed sponsor is Oxford BioMedica, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Carcinoma, Renal Cell appearing as the primary indexed condition, and to 2 interventions - of which IL-2 is the first listed.
NCT00325507 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT00325507 about?
NCT00325507 is a clinical study titled "Safety and Biological Activity of TroVax® Vaccine Given With IL-2 in Renal Cell Carcinoma". The purpose of this study is to assess the safety and tolerability of TroVax® investigational vaccine injections when given as first or second line treatment in conjunction with subcutaneous low dose IL-2 to patients with locally advanced or metastatic clear cell or papillary cell renal carcinoma. ...
What is the current status of trial NCT00325507?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2005-11. Estimated completion is 2008-07.
What conditions does trial NCT00325507 study?
This clinical trial studies the following conditions: Carcinoma, Renal Cell.
What interventions are being tested in trial NCT00325507?
The interventions under investigation include: IL-2 (DRUG), TroVax (BIOLOGICAL).
Who is sponsoring clinical trial NCT00325507?
This trial is sponsored by Oxford BioMedica, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00325507 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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