Ipilimumab + Androgen Deprivation Therapy in Prostate Cancer
The goal of this clinical research study is to learn if ipilimumab in combination with either Lupron® (leuprolide), Zoladex® (goserelin), or Firmagon® (degarelix) can affect prostate-specific antigen (PSA) levels in patients with prostate cancer. Researchers also want to learn if these drug combinations affect the body's immune system. The safety of these drug combinations will also be studied.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Ipilimumab PLUS Androgen Deprivation Therapy in Castrate Sensitive Prostate Carcinoma|
- Proportion of Participants achieving a PSA ≤ 0.2ng/mL at Month 7 [ Time Frame: Baseline to 7 months ] [ Designated as safety issue: Yes ]Prostate-specific antigen (PSA) conducted by the Simon's optimal two-stage design (Simon, 1989). Antitumor activity assessed through serial PSA measurements (blood tests) at pre-determined time points.
|Study Start Date:||June 2011|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Experimental: Ipilimumab + ADT
Ipilimumab 10 mg/kg intravenous (IV) Weeks 5, 9, 13, and 17 plus Androgen Deprivation Therapy (ADT) of either Leuprolide 7.5 mg intramuscular (IM) , Goserelin 3.6 mg subcutaneous (SQ) or Degarelix 80 mg SQ once a month for 8 months beginning Week 1.
10 mg/kg by vein over 90 minutes once every 4 weeks, for 4 weeks.
Other Names:Drug: Leuprolide
7.5 mg intramuscular once a month for 8 months
Other Names:Drug: Goserelin
3.6 mg subcutaneous once a month for 8 months
Other Name: ZoladexDrug: Degarelix
80 mg subcutaneous once a month for 8 months
Other Name: Firmagon
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|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Ana M. Aparicio, MD||UT MD Anderson Cancer Center|