A Phase I-IIa, Multicenter, Open-Label, Multiple Dose, Safety, Tolerability and Pharmacokinetic Study of Recombinant Human Hyaluronidase (Chemophase) in Combination With Mitomycin in Patients With Non-Muscular-Invasive Bladder Cancer
The primary objectives of this study are to:
1. determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of
escalating doses of Chemophase in combination with mitomycin (mitomycin C, MMC)
administered as weekly intravesical instillations for five weeks, and
2. establish the dose of Chemophase with MMC recommended for future studies.
The secondary objectives of this study are to:
1. assess the pharmacokinetics of intravesical administration of MMC alone and in
combination with intravesical administration of Chemophase,
2. for those patients treated at the MTD, assess the safety and tolerability of
intravesical administration of MMC with Chemophase over up to 7 additional maintenance
treatments every 3 months following the initial six weekly instillations, and
3. observe patients for any preliminary evidence of anti-tumor activity of MMC and
Chemophase when combined.
Study patients will receive six (6) weekly study treatments (at Weeks 1 through 6) followed
by post-treatment evaluations, at Weeks 8 and 12. The 12 patients treated at MTD will
continue to receive combination therapy every three months until the end of Year 2 or until
the time of documented tumor recurrence, whichever occurs first. For other patients,
long-term follow-up after Week 12 will consist of disease monitoring of patients by
telephone and will be performed every three (3) months beginning three months after last
study treatment for two years and then every six (6) months thereafter, until bladder tumor
recurrence.
The following therapies are prohibited from the time of enrollment through Week 12 of the
study:
- Treatment with heparin
- Any intravesical therapy except for MMC and Chemophase
- Any potentially myelosuppressive therapy
For the MTD patients who are receiving continued study drug treatments after Week 12, the
following therapies are prohibited for the duration of study drug treatment:
- Any intravesical therapy except for MMC and Chemophase
- Any potentially myelosuppressive therapy
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of escalating doses of Chemophase in combination with mitomycin C (MMC) administered weekly into the bladder for 5 weeks
United States: Food and Drug Administration
HZ2-05-01
NCT00318643
March 2006
Name | Location |
---|---|
Advanced Research Institute | New Port Richey, Florida 34652 |
James A. Haley Veterans Hospital | Tampa, Florida 33612 |
BCG Oncology | Phoenix, Arizona 85032 |
MedResearch | La Mesa, California 91942 |
Malcolm Randall Veterans Administration Urology Section (112-C) | Gainsville, Florida 32608 |