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A Safety and Tolerability Study of SCH 721015 in Patients With Transitional Cell Carcinoma of the Bladder (Study P03816AM4)
Basic Trial Information Trial Description Summary Further Trial Information Eligibility Criteria Trial Contact Information
Basic Trial Information
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Phase
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Type
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Status
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Age
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Protocol IDs
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Phase I
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Treatment
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Active
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18 to 80
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Pharmaceutical / Industry
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P03816 NCT00536588
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Trial Description
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. Further Study Information 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. Eligibility Criteria 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 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.
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.
Trial Contact Information
Trial Lead Organizations/Sponsors Schering-Plough Research Institute David Cutler, MD, FRCPC | | Study Director |
SP Clinical Trial Registry Call Center | | Ph: 1-888-772-8734 |
Trial Sites
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U.S.A. |
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Texas |
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Houston |
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| | | | | | | | Investigational Site 1 |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00536588 Information obtained from ClinicalTrials.gov on September 29, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov. Back to Top |
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