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

NCT00536588 | Completed Phase 1

• 1 other identifier: P03816
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Bladder Neoplasms

Outcome Measures

Primary Outcomes (4)

• Adverse events, laboratory safety tests, dose-limiting toxicity

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

• Adverse events, laboratory safety tests, dose-limiting toxicity

  Additional hematology on Days 4, 5, & 6.

• Adverse events, laboratory safety tests, dose-limiting toxicity

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

• Adverse events, laboratory safety tests, dose-limiting toxicity

  ECG and VS - predose and selected postdose time points.

Secondary Outcomes (5)

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

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

• Urine samples for SCH 721015 DNA content.

  Predose, Days 1-7 & 14.

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

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

• Urine cytology & FISH

  Days 1, 30 & 90

• Cystoscopy & bladder biopsies

  Screening & Day 90

Study Arms (1)

SCH 721015 with SCH 209702

EXPERIMENTAL

Genetic: SCH 721015 with SCH 209702

Interventions

SCH 721015 with SCH 209702 GENETIC

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).

SCH 721015 with SCH 209702

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 23507396 RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2007
• First Posted: September 28, 2007
• Study Start: September 1, 2006
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: March 27, 2015

Record last verified: 2015-03