Sipuleucel-T With Immediate vs. Delayed Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) Blockade for Prostate Cancer

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT01804465
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • SipT Treatment — DRUG
    All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete. SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.
  • Ipilimumab — DRUG
    Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion.

Study Details

The purpose of this study is to find out what effects taking ipilimumab, as an immediate or delayed treatment, following completion of sipuleucel-T (SipT) treatment, has on patients and their prostate cancer.

Key Dates

Start date
Apr 22, 2014
Status verified
Jul 2021
Primary completion
Feb 27, 2020
Completion
Aug 31, 2020

Study Design

Enrollment
50 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Immediate IpilimumabTreatment
    Arm 1 (Immediate Treatment) Ipilimumab Q3wks x 4 started 1 day following the final dose of SipT.
  • Experimental: Delayed IpilimumabTreatment
    Arm 2 (Delayed Treatment) Ipilimumab Q3wks x 4 started 3 weeks following the final dose of SipT.

Primary Outcome Measure

Percentage of Participants With an Immune Response to Prostatic Acid Phosphatase (PAP) and/or PA2024 [ Time Frame: Up to 20 weeks ]

Locations (2)

FacilityCityStateZIP
University of California San FranciscoSan FranciscoCalifornia94115
The University of Texas MD Anderson Cancer CenterHoustonTexas77030

Find similar trials in San Francisco, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of California San Francisco· San Francisco, CAThe University of Texas MD Anderson Cancer Center· Houston, TX

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