Bladder Preservation for Patients With Muscle Invasive Bladder Cancer With Variant Histology

What is the Purpose of this Study?

The goal of this study is to evaluate a treatment called trimodal therapy after a course of neoadjuvant therapy (treatment given as a first step to shrink a tumor before main treatment) as a way to preserve the bladder in people with muscle invasive bladder cancer (MIBC) with variant histology (when the tumor shows microscopic variations that differ from the typical cancer type). Trimodal therapy is a type of bladder preservation treatment that combines radiation therapy and chemotherapy; it has been used successfully in bladder cancer that arises from traditional urothelial cells (cells that are in the bladder). This study is investigating the use of neoadjuvant chemotherapy followed by trimodal therapy in patients whose tumors have cells that are not just urothelial in origin. Researchers also want to learn whether a biomarker test is helpful in identifying relapse or recurrence of disease after treatment. A biomarker is a biological molecule found in blood, other body fluids or tissues that may be a sign of a condition or disease; it can used to predict someone’s response to a specific treatment. The U.S. Food and Drug Administration (FDA) has approved this drug as it is being used in this study.


Eligibility

  • * Documented diagnosis of MIBC with variant histology, cT2-T4N0M0, confirmed by TURBT and CT C/A/P and/or PET.
  • * Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
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Where can I participate?

  • CS Cancer at Beverly Hills : Maria Tarallo
  • CS Cancer at Cedars-Sinai Medical Center : Maria Tarallo


More about this Clinical Trial

What is the full name of this clinical trial?

IIT2023-13-BALLAS-VHTMT: Bladder Preservation for Patients with Muscle Invasive Bladder Cancer with Variant Histology

Study Details
Disease Type/Condition

Urinary Bladder

Principal Investigator

Ballas, Leslie

Co-Investigators

Behrooz Hakimian, Charles Rosser, David Hoffman, Howard Sandler, Kevin Scher, Michael Ahdoot, Mitchell Kamrava

Age Group

Adult

Phase

II

IRB Number

STUDY00003640

ClinicalTrials.gov ID

NCT06417190

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Maria Tarallo

Email
Maria.Tarallo@cshs.org
Study Detail
Disease Type/Condition

Urinary Bladder

Principal Investigator

Ballas, Leslie

Age Group

Adult

Phase

II

IRB Number

IIT2023-13-BALLAS-VHTMT

ClinicalTrials.gov ID

NCT06417190

Key Eligibility
ClinicalTrials.gov

Contact
Name

Maria Tarallo

Email
Maria.Tarallo@cshs.org