Status:
COMPLETED
Neoadjuvant Rapamycin in Patients Undergoing Radical Cystectomy
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Conditions:
Invasive Bladder Cancer Stage II
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01827618
Start Date
April 1 2012
End Date
April 1 2014
Last Update
July 2 2015
Active Locations (1)
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1
UT Health Science Center San Antonio
San Antonio, Texas, United States, 78229