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)

NCT01316874 | Completed Phase 2

• 1 other identifier: A9301/A9302
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 39

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.

Conditions

Carcinoma in Situ; Bladder Cancer

Keywords

Valrubicin; CIS; AD 32, BCG-refractory CIS; Carcinoma in situ (CIS) previously treated with BCG

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (2)

• To evaluate the qualitative toxicities associated with intravesical therapy using AD 32 (valrubicin).

  6 weeks

• To determine the concentration of anthracyclines in the voided urine of patients who chose to participate in a urine recovery study.

  6 weeks

Study Arms (1)

AD32 (valrubicin)

EXPERIMENTAL

800mg, once weekly for 6 weeks

Drug: Valrubicin, 800 mg

Interventions

Valrubicin, 800 mg DRUG

Investigator will be responsible for regulating the use of concomitant medications (systemic and/or topical anticholinergic therapy or topical anesthesia) and other medications.

AD32 (valrubicin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (39)

Stacy Childs, MD

Alabaster, Alabama, United States

Location

William Bohnert, MD

Phoenix, Arizona, United States

Location

Scott Swanson, MD

Scottsdale, Arizona, United States

Location

Bruce Dalkin, MD

Tucson, Arizona, United States

Location

Donald Gleason, MD

Tucson, Arizona, United States

Location

William Friedel, MD

La Mesa, California, United States

Location

Stephen Auerbach, MD

Newport Beach, California, United States

Location

William Moseley, MD

San Diego, California, United States

Location

Standley Brosman, MD

Santa Monica, California, United States

Location

Eugene Dula, MD

Van Nuys, California, United States

Location

B. Thomas Brown, MD

Daytona Beach, Florida, United States

Location

Charles Jackson, MD

Fort Lauderdale, Florida, United States

Location

Marc Soloway, MD

Miami, Florida, United States

Location

Charles Brendler, MD

Chicago, Illinois, United States

Location

Patrick Guinan, MD

Chicago, Illinois, United States

Location

Jeffrey Ignatoff, MD

Evanston, Illinois, United States

Location

David Wood, MD

Lexington, Kentucky, United States

Location

John Tuttle, MD

Lexington, Kentucky, United States

Location

Dennis Venable, MD

Shreveport, Louisiana, United States

Location

Harold Frazier, MD

Bethasda, Maryland, United States

Location

Myron Murdock, MD

Greenbelt, Maryland, United States

Location

John Libertino

Burlington, Massachusetts, United States

Location

W. Lamar Weems, MD

Jackson, Mississippi, United States

Location

Hugh Fisher, MD

Albany, New York, United States

Location

Michael Blute, MD

Rochester, New York, United States

Location

Michael Wolff, MD

Burlington, North Carolina, United States

Location

Cary Robertson, MD

Durham, North Carolina, United States

Location

Eric Klein, MD

Cleveland, Ohio, United States

Location

Bruce Lowe, MD

Portland, Oregon, United States

Location

Jeffrey Cohen, MD

Pittsburgh, Pennsylvania, United States

Location

Jacques Susset, MD

Providence, Rhode Island, United States

Location

L. Dean Knoll, MD

Nashville, Tennessee, United States

Location

Steohen Hardeman, MD

Austin, Texas, United States

Location

Ian Thompson, MD

Fort San Houston, Texas, United States

Location

Seth Lemer, MD

Houston, Texas, United States

Location

Aaron Katz, MD

Richmond, Virginia, United States

Location

Gary Katz, MD

Richmond, Virginia, United States

Location

Williams Ellis, MD

Seattle, Washington, United States

Location

Richard Boxer, MD

Milwaukee, Wisconsin, United States

Location

Related Publications (2)

• 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.

  PMID: 10687972 BACKGROUND

• 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.

  PMID: 21566413 DERIVED

MeSH Terms

Conditions

Carcinoma in Situ; Urinary Bladder Neoplasms

Interventions

valrubicin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 15, 2011
• First Posted: March 16, 2011
• Study Start: November 1, 1993
• Primary Completion: April 1, 1997
• Study Completion: April 1, 1997
• Last Updated: June 12, 2015

Record last verified: 2015-06

Locations

US (39)