Trials / Completed
CompletedNCT01827618
Neoadjuvant Rapamycin in Patients Undergoing Radical Cystectomy
An Immunopharmacodynamic Phase 0/I Study of Rapamycin in Patients Undergoing Radical Cystectomy for Bladder Cancer
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 29 (actual)
- Sponsor
- The University of Texas Health Science Center at San Antonio · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study aims to evaluate the effects of rapamycin directly on bladder tumors and the effects of rapamycin on the immune system of patients with bladder cancer.
Detailed description
This is a presurgical clinical trial which aims to understand the biologic activity of TORC1 inhibition and safety in patients with bladder cancer. In this presurgical setting, paired PMBCs and tumor tissue is evaluated before and after exposure to rapamycin to address target specificity, drug delivery, physiologic effects on tumor growth and apoptosis, and correlation of biomarkers with clinical activity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rapamycin |
Timeline
- Start date
- 2012-04-01
- Primary completion
- 2014-04-01
- Completion
- 2014-04-01
- First posted
- 2013-04-09
- Last updated
- 2015-07-02
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01827618. Inclusion in this directory is not an endorsement.