Bladder Cancer Clinical Trial
Neoadjuvant Rapamycin in Patients Undergoing Radical Cystectomy
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.
Full 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.
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
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There is 1 Location for this study
San Antonio Texas, 78229, United States
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