MedTrace Logo

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

NCT00782587 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2010-02-08

No results posted yet for this study

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).

Conditions

  • Superficial Bladder Cancer

Interventions

DRUG

Chemophase

40 mg mitomycin with 800,000 U rHuPH20 total volume of 40 mL instilled

Sponsors & Collaborators

  • Halozyme Therapeutics

    lead INDUSTRY

Principal Investigators

  • Donald Lamm, M.D. · BCG Oncology, PC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-03-31
Completion
2009-08-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00782587 on ClinicalTrials.gov