A Safety and Tolerability Study of SCH 721015 in Patients With Transitional Cell Carcinoma of the Bladder (Study P03816AM4) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00536588

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 I

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety 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

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
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
SCH 721015 with SCH 209702: Experimental	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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536588

Contacts

Contact: SP Clinical Trial Registry Call Center

1-888-772-8734

Locations

United States, Texas
Investigational Site 1	Recruiting
Houston, Texas, United States, 77030

Sponsors and Collaborators

Schering-Plough

More Information

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P03816
Study First Received:	September 26, 2007
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00536588 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Urinary Tract Neoplasm
Cystocele
Urologic Diseases
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Urogenital Neoplasms

Bladder Neoplasm
Urologic Neoplasms
Carcinoma, Transitional Cell
Transitional Cell Carcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Urologic Diseases
Urinary Bladder Diseases
Urinary Bladder Neoplasms

Urogenital Neoplasms
Urologic Neoplasms
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on May 06, 2009