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

Phase 1
18 Years
Not Enrolling
Bladder Neoplasms

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Trial Information

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

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.

Inclusion Criteria:

- 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

- 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.

Exclusion Criteria:

- 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;

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse events, laboratory safety tests, dose-limiting toxicity

Outcome Time Frame:

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

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

September 2006

Completion Date:

September 2009

Related Keywords:

  • Bladder Neoplasms
  • Urinary Bladder Neoplasms
  • Neoplasms
  • Carcinoma
  • Carcinoma, Transitional Cell