Neoadjuvant Rapamycin in Patients Undergoing Radical Cystectomy

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Treatments: Everolimus; Sirolimus

Criteria

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.