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Sipuleucel-T and Ipilimumab for Advanced Prostate Cancer

Sponsor
Prostate Oncology Specialists, Inc. (Other)
Overall Status
Completed
CT.gov ID
NCT01832870
Collaborator
(none)
9
Enrollment
1
Location
1
Arm
34
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a clinical trial designed to quantify the immune response and determine the tolerability and side effects of sipuleucel-T when given in combination with ipilimumab for patients with advanced prostate cancer.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 1 Study of Sipuleucel-T and Ipilimumab in Combination for Advanced Prostate Cancer
Study Start Date :
Apr 1, 2013
Actual Primary Completion Date :
Feb 1, 2016
Actual Study Completion Date :
Feb 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment

Patients enrolled will receive the standard 3-dose treatment of sipuleucel-T, followed by treatment(s) of ipilimumab.

Drug: sipuleucel-T
Other Names:
  • Provenge

    • Drug: ipilimumab
    Other Names:
  • Yervoy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Antigen-specific memory T cell response [After last sipuleucel-T and last ipilimumab, and follow-up period, an expected average of 15 months]

      To quantify antigen-specific memory T cell response to sipuleucel-T and ipilimumab in combination.

    2. Antigen-specific T cell proliferation to PA2024, PAP and PHA [After last sipuleucel-T and last ipilimumab, and follow-up period, an expected average of 15 months]

      To quantify Antigen-specific T cell proliferation to PA2024, PAP and PHA when sipuleucel-T and ipilimumab are given in combination. PA2024 is a recombinant protein PAP: Prostatic acid phosphatase PHA: Phytohaemagglutinin, an assay control

    3. Antibody responses against PA2024 and PAP [After last sipuleucel-T and last ipilimumab, and the follow-up period, an expected average of 15 months]

      To quantify antibody responses against PA2024 and PAP. PA2024 is a recombinant protein PAP: Prostatic acid phosphatase

    Secondary Outcome Measures

    1. Prostate-Specific Antigen (PSA) doubling time [Duration of the study, an expected average of 18 months]

      To measure changes in PSA doubling time following treatment with sipuleucel-T and ipilimumab

    2. Time to PSA progression [Duration of the study, an expected average of 18 months]

      To quantify time to PSA progression after treatment with sipuleucel-T and ipilimumab

    3. Time to salvage therapy [Duration of the study, an expected average of 18 months]

      To quantify time to salvage therapy after treatment with sipuleucel-T and ipilimumab

    4. Percentage PSA decline [Duration of the study, an expected average of 18 months]

      To measure percentage PSA decline following treatment with sipuleucel-T and ipilimumab

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Subjects with advanced prostate cancer who are eligible to receive sipuleucel-T in accordance with FDA approved labeling of sipuleucel-T

    • Subjects must understand and sign an informed consent form

    Exclusion Criteria:
    • Subjects who are not eligible to receive sipuleucel-T

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Prostate Oncology Specialists, Inc. Marina del Rey California United States 90292

    Sponsors and Collaborators

    • Prostate Oncology Specialists, Inc.

    Investigators

    • Principal Investigator: Mark Scholz, MD, Prostate Oncology Specialists, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prostate Oncology Specialists, Inc.
    ClinicalTrials.gov Identifier:
    NCT01832870
    Other Study ID Numbers:
    • SIPIPI 2013
    First Posted:
    Apr 16, 2013
    Last Update Posted:
    Aug 24, 2017
    Last Verified:
    Aug 1, 2017
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Ipilimumab

    Study Results

    No Results Posted as of Aug 24, 2017