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Carcinoma in SituPhase 2/3Bladder CancerNCT01316874

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)

A Phase 2/3 study testing Valrubicin, 800 mg in people with Carcinoma in Situ and Bladder Cancer, run by Endo USA Inc., a Keenova Therapeutics Company at 39 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma in Situ, Bladder Cancer
What is being tested?
Valrubicin, 800 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
39 sitesUnited States
Study dates
Nov 1993to Apr 1997
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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).

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

United States39 sites

  • Stacy Childs, MD

    Alabaster, Alabama

  • Hugh Fisher, MD

    Albany, New York

  • Steohen Hardeman, MD

    Austin, Texas

  • Harold Frazier, MD

    Bethasda, Maryland

  • John Libertino

    Burlington, Massachusetts

  • Michael Wolff, MD

    Burlington, North Carolina

  • Charles Brendler, MD

    Chicago, Illinois

  • Patrick Guinan, MD

    Chicago, Illinois

  • Eric Klein, MD

    Cleveland, Ohio

  • B. Thomas Brown, MD

    Daytona Beach, Florida

  • Cary Robertson, MD

    Durham, North Carolina

  • Jeffrey Ignatoff, MD

    Evanston, Illinois

  • Charles Jackson, MD

    Fort Lauderdale, Florida

  • Ian Thompson, MD

    Fort San Houston, Texas

  • Myron Murdock, MD

    Greenbelt, Maryland

  • Seth Lemer, MD

    Houston, Texas

  • W. Lamar Weems, MD

    Jackson, Mississippi

  • William Friedel, MD

    La Mesa, California

  • David Wood, MD

    Lexington, Kentucky

  • John Tuttle, MD

    Lexington, Kentucky

  • Marc Soloway, MD

    Miami, Florida

  • Richard Boxer, MD

    Milwaukee, Wisconsin

  • L. Dean Knoll, MD

    Nashville, Tennessee

  • Stephen Auerbach, MD

    Newport Beach, California

  • William Bohnert, MD

    Phoenix, Arizona

  • Jeffrey Cohen, MD

    Pittsburgh, Pennsylvania

  • Bruce Lowe, MD

    Portland, Oregon

  • Jacques Susset, MD

    Providence, Rhode Island

  • Aaron Katz, MD

    Richmond, Virginia

  • Gary Katz, MD

    Richmond, Virginia

  • Michael Blute, MD

    Rochester, New York

  • William Moseley, MD

    San Diego, California

  • Standley Brosman, MD

    Santa Monica, California

  • Scott Swanson, MD

    Scottsdale, Arizona

  • Williams Ellis, MD

    Seattle, Washington

  • Dennis Venable, MD

    Shreveport, Louisiana

  • Bruce Dalkin, MD

    Tucson, Arizona

  • Donald Gleason, MD

    Tucson, Arizona

  • Eugene Dula, MD

    Van Nuys, California

Other trials in United States

About this study

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)

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.

Being tested
Valrubicin, 800 mg
Keywords
Valrubicin, CIS, AD 32, BCG-refractory CIS, Carcinoma in situ (CIS) previously treated with BCG
Medical subject headings
Carcinoma in Situ, Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Valrubicin, 800 mgDrug

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

Study groups in NCT01316874
Study groupRoleWhat they receive
AD32 (valrubicin)Experimental800mg, once weekly for 6 weeks
Receives: Drug: Valrubicin, 800 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 weeks

Secondary outcomes (2)

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

    Measured: 6 weeks

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

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2011 (estimated)
  2. Study startNov 1993
  3. Primary completionApr 1997
  4. Study completionApr 1997

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01316874
Sponsor's protocol ID
A9301/A9302
Acronym
Bladder Cancer
Status last verified
Jun 2015
First submitted
15 Mar 2011
Last updated
12 Jun 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 10687972

  • 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.

    PubMed 21566413

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Valrubicin, 800 mg in people with Carcinoma in Situ and Bladder Cancer, run by Endo USA Inc., a Keenova Therapeutics Company at 39 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01316874, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2015.

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