Invasive Bladder Cancer Stage II
Conditions
Keywords
bladder, Cancer, Cystectomy, Rapamycin
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 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.
Interventions
DRUGRapamycin
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Have invasive (≥T1) bladder cancer 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 3. In their treating physician's opinion is a good candidate for radical cystectomy 4. In their treating physician's opinion does not need neoadjuvant chemotherapy prior to cystectomy 5. Be able to give informed consent 6. Be age 18 or older 7. 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). 8. Have adequate end-organ function (GFR \>30, bilirubin \<1.5, SGOT \< 3x ULN) 9. Have a life expectancy \> one year 10. Not have a prior history of non-bladder cancer unless the cancer is clinically stable and not requiring active treatment 11. Not have received chemotherapy or radiotherapy in the prior 30 days
Exclusion criteria
1. Immunosuppressed state (e.g. HIV, use of chronic steroids) 2. Fixed disease (clinical T4) 3. Active, uncontrolled infections 4. Hepatic impairment (SGOT \>3x ULN) 5. Unhealed wounds 6. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tissue pharmacodynamic (PD) response to TORC1 inhibition | 30 days | PD response defined by significant phospho rpS6 Kinase 1 (S6K1) inhibition (comparing post-treatment to baseline). |
Countries
United States
Outcome results
None listed