Ipilimumab in Combination With Androgen Suppression Therapy in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor
OHSU Knight Cancer Institute
Study ID
NCT01498978
Phase
PHASE2
Status
Completed

Conditions

  • Adenocarcinoma of the Prostate
  • Hormone-resistant Prostate Cancer
  • Recurrent Prostate Cancer
  • Stage IV Prostate Cancer

Eligibility Criteria

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

Interventions

  • ipilimumab — BIOLOGICAL
    Given IV
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

This phase II trial studies how well ipilimumab works when given together with androgen suppression therapy in treating patients with hormone-resistant prostate cancer that has spread to other parts of the body. Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumors to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Androgen can cause the growth of prostate cancer. Androgen deprivation therapy may stop the adrenal glands from making androgen. Giving ipilimumab together with androgen suppression therapy may kill more tumor cells.

Key Dates

Start date
Feb 6, 2012
Status verified
Sep 2020
Primary completion
Feb 28, 2017
Completion
Jan 19, 2019

Study Design

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

Arms

  • Experimental: Treatment (ipilimumab)
    Patients receive ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients without progression then receive maintenance ipilimumab IV once every 3 months for 4 additional doses.

Primary Outcome Measure

Percentage of Patients Who Achieve an Undetectable PSA (=< 0.2 ng/ml) [ Time Frame: Up to 5 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
OHSU Knight Cancer InstitutePortlandOregon97239-

Find similar trials in New Brunswick, NJ

By research site
Rutgers Cancer Institute of New Jersey· New Brunswick, NJOHSU Knight Cancer Institute· Portland, OR

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