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Bladder NeoplasmsPhase 1NCT00536588

A Safety and Tolerability Study of SCH 721015 in Patients With Transitional Cell Carcinoma of the Bladder (Study P03816)

A Phase 1 study testing SCH 721015 with SCH 209702 in people with Bladder Neoplasms, run by Merck Sharp & Dohme LLC.

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

The purpose of this first-in-human study is to determine the safety and tolerability of SCH 721015 in subjects with transitional cell carcinoma of the bladder. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Neoplasms
What is being tested?
SCH 721015 with SCH 209702
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
No sites listed yet
Study dates
Sep 2006to Aug 2009
Phase
Phase 1
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

  • Histologically proven recurrent transitional cell carcinoma of the bladder, Stage Tis, Ta.
  • Patients with recurrent T1 disease who do not wish to have cystectomy.
  • Subjects must have failed at least two prior courses of BCG with or without recombinant interferon alpha administration.
  • At least 3 months must have passed since last intravesical treatment for bladder carcinoma.
  • Subjects must be 18 years of age or older.
  • Life expectancy of at least 3 months.
  • Adequate performance status (Karnofsky score >=70%).
  • Adequate laboratory values.

Who cannot join

  • Suspected hypersensitivity to interferon alpha.
  • Subjects with organ transplants.
  • Any known preexisting medical condition that could interfere with the subject's participation in and completion of the study such as:
  • History of psychosis or presence of poorly controlled depression;
  • CNS trauma or active seizure disorders requiring medication;
  • Significant cardiovascular dysfunction within the past 6 months including symptomatic cardiac ischemia, arrhythmia or congestive heart failure requiring hospitalization or emergency room visit within last 3 months;
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  • Poorly controlled diabetes mellitus (HbA1C >10.0%);
  • Unstable chronic pulmonary disease requiring hospitalization or emergency room visit within the last 3 months;
  • Immunologically mediated disease (eg, rheumatoid arthritis, autoimmune hepatitis, immune mediated glomerulonephritis).
  • History of any clinically significant local or systemic infectious disease within 4 weeks prior to initial treatment administration.
  • Untreated bladder infection.
  • Positive for hepatitis BsAg or HIV Ab or hepatitis C.
  • Immunosuppressive therapy within the last 3 months.
  • BCG therapy or intravesical therapy within 3 months.
  • Traumatic catheterization within 1 month.

About this study

Official title: A Phase 1 Study of the Safety and Tolerability of Intravesical Administration of SCH 721015 in Patients With Transitional Cell Carcinoma of the Bladder

The purpose of this first-in-human study is to determine the safety and tolerability of SCH 721015 in subjects with transitional cell carcinoma of the bladder.

Read the detailed description

A nonrandomized, open-label, rising-dose, parallel-group, multi-center study of SCH 721015 in patients with papillary bladder cancer, or carcinoma in situ that is refractory to Bacillus Calmette-Guerin. Subjects will receive a single intravesical administration of SCH 721015 with SCH 209702 in a total volume of 75 mL with a 1-hour dwell time. Subjects who at 3 months post administration demonstrate a complete response (CR on cystoscopy/biopsy and cytology) and who did not experience dose-limiting toxicity will be allowed to receive a second intravesical administration at the same dose level.

Being tested
SCH 721015 with SCH 209702
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

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

  • SCH 721015 with SCH 209702Genetic

    Each subject receives a single intravesical administration of SCH 721015 with SCH 209702 at dose levels of 1 x 10^9 to 3 x 10^11 particles/mL (based on assessment of tolerability, intermediate dose levels may be used).

Study groups in NCT00536588
Study groupRoleWhat they receive
SCH 721015 with SCH 209702ExperimentalNot described
Receives: Genetic: SCH 721015 with SCH 209702

What is being measured

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

  1. Adverse events, laboratory safety tests, dose-limiting toxicity

    Measured: CBC/chemistry: predose, Days 1-3, 7, 14, 21, & 28, Week 12.

  2. Adverse events, laboratory safety tests, dose-limiting toxicity

    Measured: Additional hematology on Days 4, 5, & 6.

  3. Adverse events, laboratory safety tests, dose-limiting toxicity

    Measured: AEs: Duration of study; up to 3 years postdose for serious events.

  4. Adverse events, laboratory safety tests, dose-limiting toxicity

    Measured: ECG and VS - predose and selected postdose time points.

Secondary outcomes (5)

  1. Timed urine collections for IFNα2b excretion & IP-10.

    Measured: Days 1-7, 10, 14, 21, & 28/29.

  2. Urine samples for SCH 721015 DNA content.

    Measured: Predose, Days 1-7 & 14.

  3. Blood samples for SCH 721015 DNA; SCH 209702, & IFNα2b levels; antiadenoviral & anti-IFNα2b antibodies

    Measured: Pre- & postdose for SCH 721015 DNA; SCH 721015, & IFNα2b levels; & postdose for antibodies.

  4. Urine cytology & FISH

    Measured: Days 1, 30 & 90

  5. Cystoscopy & bladder biopsies

    Measured: Screening & Day 90

Timeline

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

  1. First posted28 Sep 2007 (estimated)
  2. Study startSep 2006
  3. Primary completionAug 2009
  4. Study completionAug 2009

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00536588
Sponsor's protocol ID
P03816
Status last verified
Mar 2015
First submitted
26 Sep 2007
Last updated
27 Mar 2015
Results posted
No
Data monitoring committee
No

Publications

  • Dinney CP, Fisher MB, Navai N, O'Donnell MA, Cutler D, Abraham A, Young S, Hutchins B, Caceres M, Kishnani N, Sode G, Cullen C, Zhang G, Grossman HB, Kamat AM, Gonzales M, Kincaid M, Ainslie N, Maneval DC, Wszolek MF, Benedict WF. Phase I trial of intravesical recombinant adenovirus mediated interferon-alpha2b formulated in Syn3 for Bacillus Calmette-Guerin failures in nonmuscle invasive bladder cancer. J Urol. 2013 Sep;190(3):850-6. doi: 10.1016/j.juro.2013.03.030. Epub 2013 Mar 15.

    PubMed 23507396

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SCH 721015 with SCH 209702 in people with Bladder Neoplasms, run by Merck Sharp & Dohme LLC.

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 8 inclusion and 15 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 27 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

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 phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Adverse events, laboratory safety tests, dose-limiting toxicity (time frame: CBC/chemistry: predose, Days 1-3, 7, 14, 21, & 28, Week 12.). The study lists 4 primary outcomes in all. 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 NCT00536588, which also lists 1 linked publication.

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 27 Mar 2015.

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