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


Phase 0
18 Years
N/A
Open (Enrolling)
Both
Invasive Bladder Cancer Stage II

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Tissue pharmacodynamic (PD) response to TORC1 inhibition

Outcome Description:

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

Outcome Time Frame:

30 days

Safety Issue:

No

Principal Investigator

Robert S Svatek, MD,MSCI

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT Health Science Center San Antonio

Authority:

United States: Food and Drug Administration

Study ID:

HSC20120135H

NCT ID:

NCT01827618

Start Date:

April 2012

Completion Date:

April 2014

Related Keywords:

  • Invasive Bladder Cancer Stage II
  • bladder
  • Cancer
  • Cystectomy
  • Rapamycin
  • Urinary Bladder Neoplasms

Name

Location

UT Health Science Center San AntonioSan Antonio, Texas  78229