Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer
Status
RECRUITING
Phase
PHASE1
Age
≥ 18 Years
Enrollments
12Conditions
Metastatic Castration-Resistant Prostate Cancer (mCRPC)Summary
Proposed immunotherapy with an extended course of Sipuleucel-T treatment may induce a more robust immune response and improve the anti-cancer efficacy of Sipuleucel-T in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC).
Detailed Description
This open-label, pilot trial aims to evaluate the feasibility of Sipuleucel-T given in three doses at weeks 0, 2, and 12-14; and to investigate the changes in immune response in mCRPC patients who are getting an extended course of Sipuleucel-T treatment.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Kelly Stratton, MD
- 405-271-6900
- [email protected]
Principal Investigator
- Kelly Stratton, MD
Eligibility Criteria
Inclusion Criteria:
1. Men ≥ 18 years of age
2. Prostate cancer with history of metastasis
3. Candidates for Sipuleucel-T treatment are defined as those with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5. Life expectancy of ≥ 6 months
Exclusion Criteria:
1. Previously received Sipuleucel-T (Provenge®)
2. Known malignancies other than prostate cancer likely to require treatment within 6 months following registration
3. A requirement for systemic immunosuppressive therapy (>10mg Prednisone daily or equivalent)
4. A history of allergic reactions attributed to compounds of similar chemical or biologic composition to Sipuleucel-T or GM-CSF
5. Any infection requiring antibiotic therapy within 1 week prior to registration
Study Plan
Extended course of Sipuleucel-T treatment
BIOLOGICAL:
Sipuleucel-TDescription:
Three doses of Sipuleucel-T, each containing a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF, given at week 0, 2, and 12-14.
Outcome Measures
Primary Outcome Measures
Proportion of patients completing 3 doses of Sipuleucel-T immunotherapy.
Proportion of subjects who have detectable elevated IgG level and/or T-cell proliferation from baseline to the follow-up of extended course of Sipuleucel-T immunotherapy.
Secondary Outcome Measures
Evaluate the mean difference in immune response to Sipuleucel-T treatment among different racial groups.
Evaluate the potential tumor response based on the changes in serum PSA at baseline and within 30 days of last dose.
Timeline
Last Updated
June 11, 2024Start Date
April 10, 2023Today
February 5, 2025Completion Date ( Estimated )
November 1, 2024
Sponsors of this trial
Lead Sponsor
University of OklahomaCollaborating Sponsors
Dendreon
RECRUITING 
21 - 64 Years