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NCT01240824 · ClinicalTrials.gov registry record · Early Phase 1
Study of BCG + Aminophylline Toxicity When Used in the Treatment of Bladder Cancer
A Early Phase 1 study, sponsored by University of Virginia.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 3
- Enrollment target
NCT01240824: Completed Early Phase 1 study, sponsored by University of Virginia.
NCT01240824 is a Early Phase 1 study that has completed, run by University of Virginia. The registered enrollment target is 3 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01240824, a Early Phase 1 study, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate whether a new potential treatment for non invasive bladder cancer is safe and if it leads to side effects such as irregular heart rate, agitation, or burning with urination. Patients who have early stage bladder cancer and will be receiving BCG, a bladder cancer therapy as recommended by a doctor, will be asked to participate in a study where they are given the standard BCG followed by the experimental drug, aminophylline. Although we hope this medicine may one day prove to help bladder cancer patients, at the current time we do not know if it has any benefits at all. We have data in mice that suggest that aminophylline slows the growth of tumors when coupled with BCG.
Primary Outcome
Any cardiac arrythmia or seizure activity, \> grade 2 allergic reactions, fever 101.5 for \> 48 hours, \> grade 1 insomnia, \> grade 1 involuntary movements, \> grade 2 nausea / vomiting, \> grade 2 bladder spasms, dysuria or pelvic pain.
Interventions
- DRUG aminophylline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2010-07 |
| Est. Completion | 2011-02 |
| Phase | Early Phase 1 |
What the finished NCT01240824 record still lists
NCT01240824 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which aminophylline is the first listed.
NCT01240824 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01240824 about?
NCT01240824 is a clinical study titled "Study of BCG + Aminophylline Toxicity When Used in the Treatment of Bladder Cancer". The purpose of this study is to evaluate whether a new potential treatment for non invasive bladder cancer is safe and if it leads to side effects such as irregular heart rate, agitation, or burning with urination. Patients who have early stage bladder cancer and will be receiving BCG, a bladder can...
What is the current status of trial NCT01240824?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 3 participants. The study started on 2010-07. Estimated completion is 2011-02.
What interventions are being tested in trial NCT01240824?
The interventions under investigation include: aminophylline (DRUG).
Who is sponsoring clinical trial NCT01240824?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01240824's enrollment target sits among peer trials
3 1949th of 2000 higher than 28 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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