Status:
COMPLETED
Study of Neoadjuvant Ipilimumab in Patients With Urothelial Carcinoma Undergoing Surgical Resection
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Urothelial Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to learn if ipilimumab can be given safely at two different doses given to patients with urothelial cancer who are going to have surgery as part of their treatment. The im...
Eligibility Criteria
Inclusion
- Previously untreated urothelial cancer requiring surgery for treatment
- Ineligible for chemotherapy
- Adequate hematologic, kidney and liver function
Exclusion
- Sexually active and fertile individuals or partners of these individuals who are unwilling or unable to use an acceptable method of birth control for the entire trial and up to 4 weeks after the study
- Women who are pregnant or breastfeeding
- Women with a positive pregnancy test on enrollment prior to study drug administration
- Prior treatment with ipilimumab or other anti-CTLA4 antibody, or a CD137 agonist
- Concurrent malignancy, with the exception of adequately treated and cured basal or squamous cell skin cancer, or carcinoma in situ of the cervix (previous malignancy without evidence of disease for 5 years will also be allowed to enter trial)
- Autoimmune disease: subjects with a documented history of inflammatory bowel disease (including Crohn's disease and ulcerative colitis) are excluded from this study as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis \[scleroderma\], Systemic Lupus Erythematosus, autoimmune vasculitis \[e.g., Wegener's Granulomatosis\]). Subjects with motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome) are excluded from this study
- Patients deemed ineligible for surgery
- Any non-oncology vaccine therapy used for prevention of infectious diseased in the past month
- Concomitant therapy with any of the following: IL-2, interferon or other non-study immunotherapy regimens, chemotherapy; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids (used in the management of cancer or non-cancer related illnesses)
- Prior radiation therapy for urothelial cancer
- Positive screening tests for or any prior history of HIV, Hepatitis B or Hepatitis C
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00362713
Start Date
March 1 2007
End Date
October 1 2009
Last Update
September 30 2016
Active Locations (1)
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1
The University Of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030