Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Study of Immediate Post-Operative Intravesical Instillation of Chemophase® in Patients With Superficial Bladder Cancer (IPOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00782587
Recruitment Status : Completed
First Posted : October 31, 2008
Last Update Posted : February 8, 2010
Information provided by:
Halozyme Therapeutics

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 also known as rHuPH20), and mitomycin (MMC) in the treatment of superficial bladder cancer when instilled intravesically immediately after TURBT (transurethral resection of bladder tumor).

Condition or disease Intervention/treatment Phase
Superficial Bladder Cancer Drug: Chemophase Phase 1

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 believed to be candidates for IPOP intravesical chemotherapy regardless of the need for further intravesical therapy. Within 6 hours after completion of TURBT, patients will be administered a single IPOP intravesical instillation of Chemophase with a one-hour dwell time. At the end of the one-hour dwell time, the patient will be asked to fully void or, if an intravesical catheter has been left in place, the bladder will be fully drained via the catheter. Patients will return at 1 and 2 weeks post instillation for follow up visits for safety and for a cystoscopy at day 85 (per standard of care). Safety and tolerability will be assessed through physical examinations, vital signs, cystoscopy, hematology (CBC), adverse event reporting, and measurements of plasma levels of MMC.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Safety and Tolerability Study of Immediate Post-Operative Intravesical Instillation of Chemophase® (Recombinant Human Hyaluronidase in Combination With Mitomycin) in Patients With Non-Muscle-Invasive Bladder Cancer
Study Start Date : October 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: Arm 1
Single arm, open label, single dose, intravesical instillation of Chemophase (combination of rHuPH20 and mitomycin) for appropriate superficial bladder cancer patients within 6 hours of TURBT.
Drug: Chemophase
40 mg mitomycin with 800,000 U rHuPH20 total volume of 40 mL instilled

Primary Outcome Measures :
  1. Safety and Tolerability of immediate post-operative instillation of Chemophase. [ Time Frame: Day 1 instillation, and weeks 1, 2, and 12 ]

Secondary Outcome Measures :
  1. Assess plasma levels of mitomycin (MMC) after IPOP intravesical instillation. [ Time Frame: Hours 1, 2 and 3 post-instillation ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00782587

Layout table for location information
United States, Arizona
BCG Oncology, PC
Phoenix, Arizona, United States, 85032
United States, California
Advanced Urology Medical Center
Anaheim, California, United States, 92801
La Mesa, California, United States, 91942
United States, Florida
Malcolm Randall Veterans Administration
Gainesville, Florida, United States, 32608
Advanced Research Institute, Inc.
New Port Richey, Florida, United States, 34655
Sponsors and Collaborators
Halozyme Therapeutics
Layout table for investigator information
Principal Investigator: Donald Lamm, M.D. BCG Oncology, PC
Layout table for additonal information
Responsible Party: Jonathan Leff, M.D., Halozyme Therapeutics Identifier: NCT00782587    
Other Study ID Numbers: HZ2-08-01
First Posted: October 31, 2008    Key Record Dates
Last Update Posted: February 8, 2010
Last Verified: February 2010
Keywords provided by Halozyme Therapeutics:
Non-Muscle-Invasive Bladder Cancer
Superficial Bladder Cancer
recombinant human hyaluronidase
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases