Ipilimumab + Androgen Depravation Therapy in Prostate Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01377389
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — DRUG
    10 mg/kg by vein over 90 minutes once every 4 weeks, for 4 weeks.
  • Leuprolide — DRUG
    7.5 mg intramuscular once a month for 8 months
  • Goserelin — DRUG
    3.6 mg subcutaneous once a month for 8 months
  • Degarelix — DRUG
    80 mg subcutaneous once a month for 8 months

Study Details

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.

Key Dates

First listed
Jun 21, 2011
Start date
Jun 17, 2011
Status verified
Sep 2023
Primary completion
Apr 7, 2017
Completion
Apr 7, 2017

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ipilimumab + ADT
    Ipilimumab 10 mg/kg intravenous (IV) Weeks 5, 9, 13, and 17 plus Androgen Depravation 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.

Primary Outcome Measure

Number of Participants Who Progressed After 7 Months of Being on Treatment [ Time Frame: at the end of 7 months on treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

Nationwide
Prostate cancer trialsOncology trialsProstate oncology trialsMen's health trialsUrology trials
By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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