Neoadjuvant Rapamycin in Patients Undergoing Radical Cystectomy
Completed · Early Phase 1
Conditions studied: Invasive Bladder Cancer Stage II
In brief
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.
Key facts
- Study ID
- NCT01827618
- Run by
- The University of Texas Health Science Center at San Antonio
- People needed
- 29
- Starts
- 2012-04-01
- Expected to finish
- 2014-04-01
- Last updated by the study team
- 2015-07-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Have invasive (≥T1) bladder cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- In their treating physician's opinion is a good candidate for radical cystectomy
- In their treating physician's opinion does not need neoadjuvant chemotherapy prior to cystectomy
- Be able to give informed consent
- Be age 18 or older
- Have adequate marrow function (defined as granulocytes greater than 1,500 cells/mm3 hemoglobin >9.5 gm/dl or platelets more than 100,000 cells/mm3).
- Have adequate end-organ function (GFR >30, bilirubin <1.5, SGOT < 3x ULN)
- Have a life expectancy > one year
- Not have a prior history of non-bladder cancer unless the cancer is clinically stable and not requiring active treatment
- Not have received chemotherapy or radiotherapy in the prior 30 days
You may not qualify if…
- Immunosuppressed state (e.g. HIV, use of chronic steroids)
- Fixed disease (clinical T4)
- Active, uncontrolled infections
- Hepatic impairment (SGOT >3x ULN)
- Unhealed wounds
- Patients at risk of pregnancy who are unwilling or unable to take effective contraception before rapamycin therapy, during therapy, and for 12 weeks after discontinuation of therapy.
Where it is running
- UT Health Science Center San Antonio — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.