Neoadjuvant Rapamycin in Patients Undergoing Radical Cystectomy

Invasive Bladder Cancer Stage II Clinical Trial

Official title:

An Immunopharmacodynamic Phase 0/I Study of Rapamycin in Patients Undergoing Radical Cystectomy for Bladder Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01827618
• Other study ID #: HSC20120135H
• Secondary ID: KL2 TR000118-05/
• Status: Completed
• Phase: Phase 0
• First received: March 29, 2013
• Last updated: June 30, 2015
• Start date: April 2012
• Est. completion date: April 2014

Study information

• Verified date: June 2015
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Invasive Bladder Cancer Stage II
• Urinary Bladder Neoplasms

Intervention

Drug:
• Rapamycin

Locations

Country	Name	City	State
United States	UT Health Science Center San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tissue pharmacodynamic (PD) response to TORC1 inhibition	PD response defined by significant phospho rpS6 Kinase 1 (S6K1) inhibition (comparing post-treatment to baseline).	30 days	No