Pilot Trial to Investigate Immune Response to an Extended Course of Sipuleucel-T Immunotherapy in Patients With Metastatic Castration-resistant Prostate Cancer (OU-SCC-EXCITE)
University of Oklahoma
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).
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.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
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…
Interventions
- BiologicalSipuleucel-T
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.
Location
- University of Oklahoma Health Sciences Center, Stephenson Cancer CenterOklahoma City, Oklahoma