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Intravesical AD 32 (Valrubicin) in Patients With Carcinoma in Situ (CIS) of the Bladder Who Have Failed or Have Recurrence Following Treatment With Bacillus Calmette-guerin (BCG) (Bladder Cancer)

Primary Purpose

Carcinoma in Situ, Bladder Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Valrubicin, 800 mg
Sponsored by
Endo Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma in Situ focused on measuring Valrubicin, CIS, AD 32, BCG-refractory CIS, Carcinoma in situ (CIS) previously treated with BCG

Eligibility Criteria

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

Inclusion-

  1. Patients must have pathologically-proven CIS with no evidence of muscle invasive disease.
  2. Patients with concurrent Ta or T1 papillary tumors are eligible provided papillary tumor(s) are resected prior to study treatment. Cystoscopic evaluation and, if indicated, transurethral resection of bladder tumor (TURBT) must be performed within 28 days of study treatment.
  3. Patients must have received at least two or more prior courses of intravesical therapy for CIS per the recommended schedules. BCG must have been one of the prior therapies administered. Patients can have either failed BCG therapy or have been successfully treated with BCG, but subsequently found to have recurrence. The standard course of intravesical therapy must include six weekly treatments (allowable range of instillations per course is 4-9).
  4. Patients must have a positive urine cytology at baseline (<28 days) prior to the first AD 32 (valrubicin) treatment. Patients with papillary lesions must have a positive cytology following TURBT or have a baseline cytology that was negative or equivocal and histologic confirmation of CIS.
  5. Patients must have an ECOG performance status of 0-2 and a life expectancy of at least 6 months.

Exclusion-

  1. Patients with urogenital tumors with histology other than transitional cell carcinoma
  2. Patients with residual papillary disease at the time of study treatment.
  3. Patients with a history of other primary malignancy (other than squamous or basal cell skin cancers) within the last 5 years.
  4. Patients with evidence of muscle invasive disease (stage higher than T1).
  5. Patients with any previous intravesical treatment with AD 32 (valrubicin).
  6. Patients with any intravesical therapy within 28 days prior to first AD 32 (valrubicin) treatment.
  7. Patients with a plan to receive other concurrent therapy for treatment of primary treatment tumor during participation in this study.
  8. Patients who had received prior systemic or radiation therapy for bladder cancer.
  9. Women who were pregnant or lactating. Individuals of reproductive potential could not participate unless agreeing to use an effective contraceptive method for themselves and/or their sexual partners.
  10. Patients who, in the investigator's opinion, could not comply with the provisions of the protocol or did not understand the nature of the study.
  11. Patients who, in the opinion of the investigator, could not tolerate intravesical administration of approximately 75 mL of fluid or who could not tolerate surgical manipulation (cystoscopy, mapping biopsies, barbotage) due to the presence of concomitant serious illnesses (ie, uncontrolled cardiac or respiratory disorders).

Sites / Locations

  • Stacy Childs, MD
  • William Bohnert, MD
  • Scott Swanson, MD
  • Bruce Dalkin, MD
  • Donald Gleason, MD
  • William Friedel, MD
  • Stephen Auerbach, MD
  • William Moseley, MD
  • Standley Brosman, MD
  • Eugene Dula, MD
  • B. Thomas Brown, MD
  • Charles Jackson, MD
  • Marc Soloway, MD
  • Charles Brendler, MD
  • Patrick Guinan, MD
  • Jeffrey Ignatoff, MD
  • David Wood, MD
  • John Tuttle, MD
  • Dennis Venable, MD
  • Harold Frazier, MD
  • Myron Murdock, MD
  • John Libertino
  • W. Lamar Weems, MD
  • Hugh Fisher, MD
  • Michael Blute, MD
  • Michael Wolff, MD
  • Cary Robertson, MD
  • Eric Klein, MD
  • Bruce Lowe, MD
  • Jeffrey Cohen, MD
  • Jacques Susset, MD
  • L. Dean Knoll, MD
  • Steohen Hardeman, MD
  • Ian Thompson, MD
  • Seth Lemer, MD
  • Aaron Katz, MD
  • Gary Katz, MD
  • Williams Ellis, MD
  • Richard Boxer, MD

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AD32 (valrubicin)

Arm Description

800mg, once weekly for 6 weeks

Outcomes

Primary Outcome Measures

Assess the efficacy of AD 32 (valrubicin) in patients with CIS of the bladder who previously have been treated with BCG for CIS and in whom recurrence or failure had occurred after multiple courses of intravesical treatment.

Secondary Outcome Measures

To evaluate the qualitative toxicities associated with intravesical therapy using AD 32 (valrubicin).
To determine the concentration of anthracyclines in the voided urine of patients who chose to participate in a urine recovery study.

Full Information

First Posted
March 15, 2011
Last Updated
June 10, 2015
Sponsor
Endo Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01316874
Brief Title
Intravesical AD 32 (Valrubicin) in Patients With Carcinoma in Situ (CIS) of the Bladder Who Have Failed or Have Recurrence Following Treatment With Bacillus Calmette-guerin (BCG)
Acronym
Bladder Cancer
Official Title
Intravesical AD 32 (Valrubicin) in Patients With Carcinoma in Situ (CIS) of the Bladder Who Have Failed or Have Recurrence Following Treatment With Bacillus Calmette-Guerin (BCG)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
November 1993 (undefined)
Primary Completion Date
April 1997 (Actual)
Study Completion Date
April 1997 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Endo Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a Phase II/Phase III study of intravesical AD 32 (valrubicin) in patients with carcinoma in situ (CIS) who have been previously treated with intravesical Bacillus Calmette-Guerin (BCG) for CIS and in whom recurrence or failure has occurred after multiple courses of intravesical treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma in Situ, Bladder Cancer
Keywords
Valrubicin, CIS, AD 32, BCG-refractory CIS, Carcinoma in situ (CIS) previously treated with BCG

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AD32 (valrubicin)
Arm Type
Experimental
Arm Description
800mg, once weekly for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Valrubicin, 800 mg
Intervention Description
Investigator will be responsible for regulating the use of concomitant medications (systemic and/or topical anticholinergic therapy or topical anesthesia) and other medications.
Primary Outcome Measure Information:
Title
Assess the efficacy of AD 32 (valrubicin) in patients with CIS of the bladder who previously have been treated with BCG for CIS and in whom recurrence or failure had occurred after multiple courses of intravesical treatment.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
To evaluate the qualitative toxicities associated with intravesical therapy using AD 32 (valrubicin).
Time Frame
6 weeks
Title
To determine the concentration of anthracyclines in the voided urine of patients who chose to participate in a urine recovery study.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion- Patients must have pathologically-proven CIS with no evidence of muscle invasive disease. Patients with concurrent Ta or T1 papillary tumors are eligible provided papillary tumor(s) are resected prior to study treatment. Cystoscopic evaluation and, if indicated, transurethral resection of bladder tumor (TURBT) must be performed within 28 days of study treatment. Patients must have received at least two or more prior courses of intravesical therapy for CIS per the recommended schedules. BCG must have been one of the prior therapies administered. Patients can have either failed BCG therapy or have been successfully treated with BCG, but subsequently found to have recurrence. The standard course of intravesical therapy must include six weekly treatments (allowable range of instillations per course is 4-9). Patients must have a positive urine cytology at baseline (<28 days) prior to the first AD 32 (valrubicin) treatment. Patients with papillary lesions must have a positive cytology following TURBT or have a baseline cytology that was negative or equivocal and histologic confirmation of CIS. Patients must have an ECOG performance status of 0-2 and a life expectancy of at least 6 months. Exclusion- Patients with urogenital tumors with histology other than transitional cell carcinoma Patients with residual papillary disease at the time of study treatment. Patients with a history of other primary malignancy (other than squamous or basal cell skin cancers) within the last 5 years. Patients with evidence of muscle invasive disease (stage higher than T1). Patients with any previous intravesical treatment with AD 32 (valrubicin). Patients with any intravesical therapy within 28 days prior to first AD 32 (valrubicin) treatment. Patients with a plan to receive other concurrent therapy for treatment of primary treatment tumor during participation in this study. Patients who had received prior systemic or radiation therapy for bladder cancer. Women who were pregnant or lactating. Individuals of reproductive potential could not participate unless agreeing to use an effective contraceptive method for themselves and/or their sexual partners. Patients who, in the investigator's opinion, could not comply with the provisions of the protocol or did not understand the nature of the study. Patients who, in the opinion of the investigator, could not tolerate intravesical administration of approximately 75 mL of fluid or who could not tolerate surgical manipulation (cystoscopy, mapping biopsies, barbotage) due to the presence of concomitant serious illnesses (ie, uncontrolled cardiac or respiratory disorders).
Facility Information:
Facility Name
Stacy Childs, MD
City
Alabaster
State/Province
Alabama
Country
United States
Facility Name
William Bohnert, MD
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Scott Swanson, MD
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
Bruce Dalkin, MD
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Donald Gleason, MD
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
William Friedel, MD
City
La Mesa
State/Province
California
Country
United States
Facility Name
Stephen Auerbach, MD
City
Newport Beach
State/Province
California
Country
United States
Facility Name
William Moseley, MD
City
San Diego
State/Province
California
Country
United States
Facility Name
Standley Brosman, MD
City
Santa Monica
State/Province
California
Country
United States
Facility Name
Eugene Dula, MD
City
Van Nuys
State/Province
California
Country
United States
Facility Name
B. Thomas Brown, MD
City
Daytona Beach
State/Province
Florida
Country
United States
Facility Name
Charles Jackson, MD
City
Ft. Lauderdale
State/Province
Florida
Country
United States
Facility Name
Marc Soloway, MD
City
Miami
State/Province
Florida
Country
United States
Facility Name
Charles Brendler, MD
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Patrick Guinan, MD
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Jeffrey Ignatoff, MD
City
Evanston
State/Province
Illinois
Country
United States
Facility Name
David Wood, MD
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
John Tuttle, MD
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
Dennis Venable, MD
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Harold Frazier, MD
City
Bethasda
State/Province
Maryland
Country
United States
Facility Name
Myron Murdock, MD
City
Greenbelt
State/Province
Maryland
Country
United States
Facility Name
John Libertino
City
Burlington
State/Province
Massachusetts
Country
United States
Facility Name
W. Lamar Weems, MD
City
Jackson
State/Province
Mississippi
Country
United States
Facility Name
Hugh Fisher, MD
City
Albany
State/Province
New York
Country
United States
Facility Name
Michael Blute, MD
City
Rochester
State/Province
New York
Country
United States
Facility Name
Michael Wolff, MD
City
Burlington
State/Province
North Carolina
Country
United States
Facility Name
Cary Robertson, MD
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Eric Klein, MD
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Bruce Lowe, MD
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Jeffrey Cohen, MD
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Jacques Susset, MD
City
Providence
State/Province
Rhode Island
Country
United States
Facility Name
L. Dean Knoll, MD
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Steohen Hardeman, MD
City
Austin
State/Province
Texas
Country
United States
Facility Name
Ian Thompson, MD
City
Ft. San Houston
State/Province
Texas
Country
United States
Facility Name
Seth Lemer, MD
City
Houston
State/Province
Texas
Country
United States
Facility Name
Aaron Katz, MD
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Gary Katz, MD
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Williams Ellis, MD
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Richard Boxer, MD
City
Milwaukee
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10687972
Citation
Steinberg G, Bahnson R, Brosman S, Middleton R, Wajsman Z, Wehle M. Efficacy and safety of valrubicin for the treatment of Bacillus Calmette-Guerin refractory carcinoma in situ of the bladder. The Valrubicin Study Group. J Urol. 2000 Mar;163(3):761-7. Erratum In: J Urol. 2008 Jan;179(1):386.
Results Reference
background
PubMed Identifier
21566413
Citation
Steinberg GD, Smith ND, Ryder K, Strangman NM, Slater SJ. Factors affecting valrubicin response in patients with bacillus Calmette-Guerin-refractory bladder carcinoma in situ. Postgrad Med. 2011 May;123(3):28-34. doi: 10.3810/pgm.2011.05.2281.
Results Reference
derived

Learn more about this trial

Intravesical AD 32 (Valrubicin) in Patients With Carcinoma in Situ (CIS) of the Bladder Who Have Failed or Have Recurrence Following Treatment With Bacillus Calmette-guerin (BCG)

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