Status:
COMPLETED
Study of Immediate Post-Operative Intravesical Instillation of Chemophase® in Patients With Superficial Bladder Cancer
Lead Sponsor:
Halozyme Therapeutics
Conditions:
Superficial Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this research study is to test the safety and tolerability of an experimental drug, Chemophase, a combination of recombinant human hyaluronidase, (an investigational synthetic enzyme al...
Detailed Description
Patients will be screened and enrolled prior to undergoing standard of care TURBT for known or suspected Stage Ta, T1 or Tis bladder cancer of any histological grade requiring TURBT and who are believ...
Eligibility Criteria
Inclusion
- Patient with histologically confirmed or suspected (based on cystoscopy) initial presentation or recurrence of Stage Ta, T1, or Tis transitional cell bladder cancer of any histological grade requiring TURBT.
- Patient believed to be a candidate for immediate post-operative chemotherapy regardless of the need for additional intravesical therapy.
- ECOG performance status of Grade 0 or 1.
- Age ≥ 18 years.
- A negative urine or serum pregnancy test (if female of child-bearing potential) within 14 days prior to Day 1/Week 1.
- Acceptable liver function within 14 days prior to Day 1/Week 1 defined as:
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN), and
- AST (SGOT), ALT (SGPT), and alkaline phosphatase ≤ 2.5 times ULN.
- Acceptable renal function within 14 days prior to Day 1/Week 1 defined as serum creatinine ≤ 1.5 x ULN.
- Acceptable hematologic status within 14 days prior to Day 1/Week 1 defined as:
- Absolute neutrophil count (ANC) ≥ 1,500/dL,
- Platelet count ≥ 100,000/dL, and
- Hemoglobin ≥ 10.0 g/dL.
- Urinalysis showing no clinically significant abnormalities, except those attributable to bladder cancer.
- For men and women of child-producing potential, agreement to use an effective contraceptive method during the study from enrollment until 2 weeks after the administration of study drug.
- Signed, written, IRB-approved informed consent.
Exclusion
- Large resected area (estimated total area \> 50 cm²) or suspected deep resection, even in the absence of signs of perforation beyond the muscularis propria or ongoing significant bleeding.
- Known or suspected bladder perforation during TURBT.
- Failure to completely resect all cancerous lesions or suspected presence of muscle-invasive cancer (Stage T2 or higher).
- Previous diagnosis or current presence of bladder fibrosis/contracture, or total bladder capacity estimated at cystoscopy or by other means to be \< 150 mL.
- Urinary incontinence or severe irritative voiding symptoms such as urgency, frequency, or nocturia of a severity that would compromise the ability of the patient to retain the study drug intravesical instillation for one hour.
- Bladder cancer recurrence less than 3 months after a previous TURBT.
- Major surgery, other than TURBT or diagnostic surgery, within 28 days prior to Day 1/Week 1.
- Known active, uncontrolled bacterial, viral, or fungal infections, including urinary tract infection.
- Any intravesical therapy within 3 months prior to Week 1/Day 1.
- Systemic therapy including radiation therapy, surgery, chemotherapy, or investigational therapy within one month prior to Day 1/Week 1 (two months for nitrosoureas or MMC), unless given as standard treatment for bladder cancer and provided that patient is free of all treatment-related toxicities as of Day 1/Week 1.
- Known infection with HIV.
- Known active infection with hepatitis B or hepatitis C virus.
- Serious disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor (Halozyme).
- History of hypersensitivity or idiosyncratic reaction to, or other contraindication to, MMC.
- Known allergy to bee or vespid venom.
- Known coagulation disorder or bleeding tendency.
- Ongoing treatment with heparin or other anticoagulation therapy, or anticipation of such therapy during the treatment period in this study.
- Unwillingness or inability to comply with procedures required in this protocol.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00782587
Start Date
October 1 2008
End Date
August 1 2009
Last Update
February 8 2010
Active Locations (5)
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1
BCG Oncology, PC
Phoenix, Arizona, United States, 85032
2
Advanced Urology Medical Center
Anaheim, California, United States, 92801
3
Medresearch
La Mesa, California, United States, 91942
4
Malcolm Randall Veterans Administration
Gainesville, Florida, United States, 32608