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NCT00083941 · ClinicalTrials.gov registry record · Phase 2
A Study of TroVax Vaccine Given in Conjunction With IL-2 for Treatment of Stage IV Renal Cell Cancer
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
NCT00083941: Completed Phase 2 study of Carcinoma, Renal Cell, sponsored by Oxford BioMedica.
NCT00083941 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. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00083941, 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 test the safety of an investigational vaccine called TroVax when given in conjunction with Interleukin-2 (IL-2) treatment. TroVax is the experimental product in this trial and its value as a medicine has not yet been proven. Interleukin-2 (IL-2) is standard treatment for your cancer, which means that you could receive it even if you choose 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 a vaccine. 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 them 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 calls. 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 receive TroVax while being treated with IL-2.
Primary Outcome
incidence of adverse events, laboratory tests and occurrence of dose limiting toxicity
Conditions Studied
Interventions
- BIOLOGICAL Interleukin-2
- BIOLOGICAL TroVax
Study Locations (1)
New York
- Columbia Presbyterian Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2004-08 |
| Est. Completion | 2008-07 |
| Phase | Phase 2 |
What the finished NCT00083941 record still lists
NCT00083941 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 283-participant average among 34 other Carcinoma, Renal Cell trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Carcinoma, Renal Cell appearing as the primary indexed condition, and to 2 interventions - of which Interleukin-2 is the first listed.
NCT00083941 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT00083941 about?
NCT00083941 is a clinical study titled "A Study of TroVax Vaccine Given in Conjunction With IL-2 for Treatment of Stage IV Renal Cell Cancer". The purpose of this study is to test the safety of an investigational vaccine called TroVax when given in conjunction with Interleukin-2 (IL-2) treatment. TroVax is the experimental product in this trial and its value as a medicine has not yet been proven. Interleukin-2 (IL-2) is standard treatment ...
What is the current status of trial NCT00083941?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2004-08. Estimated completion is 2008-07.
What conditions does trial NCT00083941 study?
This clinical trial studies the following conditions: Carcinoma, Renal Cell.
What interventions are being tested in trial NCT00083941?
The interventions under investigation include: Interleukin-2 (BIOLOGICAL), TroVax (BIOLOGICAL).
Who is sponsoring clinical trial NCT00083941?
This trial is sponsored by Oxford BioMedica, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00083941 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Carcinoma, Renal Cell
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00083941's enrollment target sits among peer trials
25 31st of 34 higher than 3 of 34 other Carcinoma, Renal Cell trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Carcinoma, Renal Cell 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.
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