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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

Phase 1
18 Years
Not Enrolling
Superficial Bladder Cancer

Thank you

Trial Information

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

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.

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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and Tolerability of immediate post-operative instillation of Chemophase.

Outcome Time Frame:

Day 1 instillation, and weeks 1, 2, and 12

Safety Issue:


Principal Investigator

Donald Lamm, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

BCG Oncology, PC


United States: Food and Drug Administration

Study ID:




Start Date:

October 2008

Completion Date:

August 2009

Related Keywords:

  • Superficial Bladder Cancer
  • Non-Muscle-Invasive Bladder Cancer
  • Superficial Bladder Cancer
  • recombinant human hyaluronidase
  • rHuPH20
  • Chemophase®
  • Mitomycin
  • Urinary Bladder Neoplasms



Advanced Urology Medical Center Anaheim, California  92801
Advanced Research Institute, Inc. New Port Richey, Florida  34652
MedResearch La Mesa, California  91942
BCG Oncology, PC Phoenix, Arizona  85032
Malcolm Randall Veterans Administration Gainesville, Florida  32608