Neoadjuvant Rapamycin in Patients Undergoing Radical Cystectomy

June 30, 2015 updated by: Robert Svatek, The University of Texas Health Science Center at San Antonio

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • UT Health Science Center San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Rapamycin
Rapamycin 3mg orally daily x 4weeks prior to radical cystectomy
Drug: Rapamycin
Other Names:
  • Sirolimus, Rapamune

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tissue pharmacodynamic (PD) response to TORC1 inhibition
Time Frame: 30 days
PD response defined by significant phospho rpS6 Kinase 1 (S6K1) inhibition (comparing post-treatment to baseline).
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Investigators

  • Principal Investigator: Robert S Svatek, MD,MSCI, UT Health Science Center San Antonio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

March 29, 2013

First Submitted That Met QC Criteria

April 8, 2013

First Posted (Estimate)

April 9, 2013

Study Record Updates

Last Update Posted (Estimate)

July 2, 2015

Last Update Submitted That Met QC Criteria

June 30, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC20120135H
  • KL2TR000118-05CTSA (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Invasive Bladder Cancer Stage II

Clinical Trials on Rapamycin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe