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Sponsored by: |
Halozyme Therapeutics |
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Information provided by: | Halozyme Therapeutics |
ClinicalTrials.gov Identifier: | NCT00782587 |
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 | Intervention | Phase |
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Superficial Bladder Cancer |
Drug: Chemophase |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
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 |
Estimated Enrollment: | 12 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Experimental
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.
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Drug: Chemophase
40 mg mitomycin with 800,000 U rHuPH20 total volume of 40 mL instilled
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
BCG Oncology, PC | Not yet recruiting |
Phoenix, Arizona, United States, 85032 | |
Contact: Donald Lamm, M.D. 602-493-6626 dlamm@bcgoncology.com | |
Contact: Mary Heeley 602-923-1327 maryheeley@yahoo.com | |
Principal Investigator: Donald Lamm, M.D. | |
United States, California | |
MEDRESEARCH | Not yet recruiting |
La Mesa, California, United States, 91942 | |
Contact: Franklin Gaylis, M.D. 619-697-2456 gaylisf@aol.com | |
Contact: Brian Hamblen 619-644-3114 brianhamblen@yahoo.com | |
Principal Investigator: Franklin Gaylis, M.D. | |
Advanced Urology Medical Center | Not yet recruiting |
Anaheim, California, United States, 92801 | |
Contact: Alfred A Sidhom, M.D. 714-776-7090 asidhom@aol.com | |
Contact: Vera Martinez 714-776-7090 | |
Principal Investigator: Alfred A Sidhom, M.D. | |
United States, Florida | |
Malcolm Randall Veterans Administration | Not yet recruiting |
Gainesville, Florida, United States, 32608 | |
Contact: Unyime O Nseyo, M.D. 352-376-1611 ext 4189 Unyime.Nseyo2@va.gov | |
Contact: Maria Mejia 352-376-1611 ext 6952 maria.mejia@va.gov | |
Principal Investigator: Unyime O Nseyo, M.D. | |
Advanced Research Institute, Inc. | Recruiting |
New Port Richey, Florida, United States, 34655 | |
Contact: Ramon Perez, M.D. 727-372-7014 srandall@advancedresearchinstitute.net | |
Contact: Susan Randall, RN 727-835-3261 srandall@advancedresearchinstitute.net | |
Principal Investigator: Ramon Perez, M.D. |
Principal Investigator: | Donald Lamm, M.D. | BCG Oncology, PC |
Responsible Party: | Halozyme Therapeutics ( Richard Yocum, M.D. ) |
Study ID Numbers: | HZ2-08-01 |
Study First Received: | October 29, 2008 |
Last Updated: | October 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00782587 |
Health Authority: | United States: Food and Drug Administration |
Non-Muscle-Invasive Bladder Cancer Superficial Bladder Cancer recombinant human hyaluronidase |
rHuPH20 Chemophase® Mitomycin |
Cystocele Urologic Diseases Mitomycin Urinary Bladder Diseases Urinary Bladder Neoplasms |
Urogenital Neoplasms Urologic Neoplasms Mitomycins Urinary tract neoplasm Bladder neoplasm |
Neoplasms Neoplasms by Site Antineoplastic Agents |
Therapeutic Uses Antibiotics, Antineoplastic Pharmacologic Actions |