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Neoadjuvant Rapamycin in Patients Undergoing Radical Cystectomy

Primary Purpose

Invasive Bladder Cancer Stage II

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Rapamycin

About this trial

This is an interventional treatment trial for Invasive Bladder Cancer Stage II focused on measuring bladder, Cancer, Cystectomy, Rapamycin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

UT Health Science Center San Antonio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Rapamycin

Control

Arm Description

Rapamycin 3mg orally daily x 4weeks prior to radical cystectomy

Outcomes

Primary Outcome Measures

Tissue pharmacodynamic (PD) response to TORC1 inhibition

PD response defined by significant phospho rpS6 Kinase 1 (S6K1) inhibition (comparing post-treatment to baseline).

Secondary Outcome Measures

Full Information

NCT ID

NCT01827618

First Posted

March 29, 2013

Last Updated

June 30, 2015

Sponsor

The University of Texas Health Science Center at San Antonio

1. Study Identification

Unique Protocol Identification Number

NCT01827618

Brief Title

Neoadjuvant Rapamycin in Patients Undergoing Radical Cystectomy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

April 2012 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center at San Antonio

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Invasive Bladder Cancer Stage II

Keywords

bladder, Cancer, Cystectomy, Rapamycin

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rapamycin

Arm Type

Experimental

Arm Description

Rapamycin 3mg orally daily x 4weeks prior to radical cystectomy

Arm Title

Control

Arm Type

No Intervention

Intervention Type

Drug

Intervention Name(s)

Rapamycin

Other Intervention Name(s)

Sirolimus, Rapamune

Primary Outcome Measure Information:

Title

Tissue pharmacodynamic (PD) response to TORC1 inhibition

Description

PD response defined by significant phospho rpS6 Kinase 1 (S6K1) inhibition (comparing post-treatment to baseline).

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert S Svatek, MD,MSCI

Organizational Affiliation

UT Health Science Center San Antonio

Official's Role

Principal Investigator

Facility Information:

Facility Name

UT Health Science Center San Antonio

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Neoadjuvant Rapamycin in Patients Undergoing Radical Cystectomy

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