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A Retrospective Analysis to Evaluate the Effectiveness, Safety and Tolerability of Intravesical Valrubicin for the Treatment of Bladder Carcinoma in Situ in Clinical Practice


N/A
18 Years
N/A
Not Enrolling
Both
Carcinoma in Situ of Bladder

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Trial Information

A Retrospective Analysis to Evaluate the Effectiveness, Safety and Tolerability of Intravesical Valrubicin for the Treatment of Bladder Carcinoma in Situ in Clinical Practice


Initial treatment for bladder CIS is TURBT followed by intravesical immunotherapy with BCG.
Valrubicin is approved by the FDA for the treatment of BCG-refractory bladder CIS in
patients for whom immediate cystectomy would be associated with unacceptable morbidity or
mortality. The recommended course of therapy is 6 doses of 800 mg each administered
intravesically once a week. While the benefit risk profile of valrubicin has been
established in several clinical trials, current data on effectiveness and tolerability when
used in clinical practice are lacking. This protocol outlines a retrospective study to
evaluate the effectiveness, safety and tolerability of intravesical valrubicin in the
treatment of NMIBC in a clinical practice setting.


Inclusion Criteria:



- age 18 years old or greater

- diagnosis of CIS (physician defined in the medical record)

- treated with at least one IVe dose of valrubicin since 10/2009 and completed
prescribed therapy or no longer receiving therapy at time of study enrollment

- willing and able to provide informed consent (unless waiver of informed consent is
applicable and in place at that clinical site per Chapter 45 CFR part 46 Subpart A
46.117

Exclusion Criteria:

- route of administration of valrubicin other than intravesical

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Retrospective

Outcome Measure:

Event-free survival

Outcome Description:

Event-free survival defined as recurrence, progression or death from any cause

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Michael Cookson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt University

Authority:

United States: Institutional Review Board

Study ID:

EN3329-401

NCT ID:

NCT01304173

Start Date:

March 2011

Completion Date:

October 2011

Related Keywords:

  • Carcinoma in Situ of Bladder
  • BCG
  • refractory
  • NMIBC
  • CIS
  • non-muscle invasive
  • Carcinoma
  • Carcinoma in Situ
  • Urinary Bladder Neoplasms

Name

Location
Vanderbilt University Nashville, Tennessee  37232-6305