A Safety and Tolerability Study of SCH 721015 in Patients With Transitional Cell Carcinoma of the Bladder (Study P03816AM4)
This study has been completed.
Sponsor:
Schering-Plough
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00536588
First received: September 26, 2007
Last updated: December 3, 2009
Last verified: December 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Neoplasms |
Genetic: SCH 721015 with SCH 209702 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Schering-Plough:
Primary Outcome Measures:
- Adverse events, laboratory safety tests, dose-limiting toxicity [ Time Frame: CBC/chemistry: predose, Days 1-3, 7, 14, 21, & 28, Week 12. ] [ Designated as safety issue: Yes ]
- Adverse events, laboratory safety tests, dose-limiting toxicity [ Time Frame: Additional hematology on Days 4, 5, & 6. ] [ Designated as safety issue: Yes ]
- Adverse events, laboratory safety tests, dose-limiting toxicity [ Time Frame: AEs: Duration of study; up to 3 years postdose for serious events. ] [ Designated as safety issue: Yes ]
- Adverse events, laboratory safety tests, dose-limiting toxicity [ Time Frame: ECG and VS - predose and selected postdose time points. ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Timed urine collections for IFNα2b excretion & IP-10. [ Time Frame: Days 1-7, 10, 14, 21, & 28/29. ] [ Designated as safety issue: No ]
- Urine samples for SCH 721015 DNA content. [ Time Frame: Predose, Days 1-7 & 14. ] [ Designated as safety issue: No ]
- Blood samples for SCH 721015 DNA; SCH 209702, & IFNα2b levels; antiadenoviral & anti-IFNα2b antibodies [ Time Frame: Pre- & postdose for SCH 721015 DNA; SCH 721015, & IFNα2b levels; & postdose for antibodies. ] [ Designated as safety issue: No ]
- Urine cytology & FISH [ Time Frame: Days 1, 30 & 90 ] [ Designated as safety issue: No ]
- Cystoscopy & bladder biopsies [ Time Frame: Screening & Day 90 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2006 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: SCH 721015 with SCH 209702 |
Genetic: SCH 721015 with SCH 209702
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).
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00536588 History of Changes |
| Other Study ID Numbers: | P03816 |
| Study First Received: | September 26, 2007 |
| Last Updated: | December 3, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Neoplasms Carcinoma Carcinoma, Transitional Cell Urologic Neoplasms Urogenital Neoplasms |
Neoplasms by Site Urinary Bladder Diseases Urologic Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 16, 2013