CLINICAL TRIAL SUMMARY

MDACC Study No:2006-0080 (clinicaltrials.gov NCT No: NCT00362713)
Title:A Phase 1b Safety and Dose-Assessment Study of Neoadjuvant Ipilimumab Monotherapy in Patients with Urothelial Carcinoma Undergoing Surgical Resection.(CA184027)
Principal Investigator:Padmanee Sharma
Treatment Agent:MDX-010
Study Status:Terminated
Study Description:The goal of this clinical research study is to find the highest tolerable dose
(from 2 established dose levels) of ipilimumab that can be given to patients
with bladder cancer who are scheduled for cystectomy and/or
nephroureterectomy. Researchers also want to study the safety and effectiveness
of this drug.

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Disease Group:Bladder
Phase of Study:Phase I
Treatment Agents:MDX-010
Treatment Location:Only at MDACC
Estimated Length of Stay in Houston:Participants will be hospitalized to undergo schedule surgery to remove the
disease site.
Supported By:N/A
Return Visit:Patients will be required to return at Week 4 and Week 7 while on treatment.
The participants will have surgery during Week 8 and will return for follow-up
once between Weeks 12-16 and at Week 24.
Home Care:N/A


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Physician Name:Padmanee Sharma
Dept:Genitourinary Medical Oncology
For Clinical Trial Enrollment:713-792-2830
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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