Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Extended course of Sipuleucel-T treatment
|
Biological: Sipuleucel-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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Proportion of patients completing 3 doses of Sipuleucel-T immunotherapy. [up to 5 months]
Patients will be treated with Sipuleucel-T immunotherapy and the treatment regimen will be considered feasible if 85% of enrolled patients complete all three infusions of Sipuleucel-T treatment given at week 0, 2 and 12-14.
- 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. [up to 12 Months]
For patients undergoing Sipuleucel-T treatment on weeks 0, 2 and 12-14, the changes in immune response will be measured based on the detectable elevated levels of IgG and/or T-cell proliferation against various types of prostate cancer associated antigens at baseline, and at Sipuleucel-T infusion doses given at week 0, 2 and 12-14 weeks.
Secondary Outcome Measures
- Evaluate the mean difference in immune response to Sipuleucel-T treatment among different racial groups. [up to 12 months]
Potential difference of immune response to Sipuleucel-T immunotherapy given at weeks 0, 2 and 12-14 will be compared in patients with mCRPC of different racial groups using the one-way ANOVA or the Kruskal-Wallis test.
- Evaluate the potential tumor response based on the changes in serum PSA at baseline and within 30 days of last dose. [up to 12 Months]
For patients undergoing Sipuleucel-T treatment on weeks 0, 2 and 12-14, the preliminary tumor response will be measure through the comparison of serum PSA level between baseline and within 30 days of last dose.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Men ≥ 18 years of age
-
Prostate cancer with history of metastasis
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Candidate for Sipuleucel-T treatment
-
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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Life expectancy of ≥ 6 months
Exclusion Criteria:
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Previously received Sipuleucel-T (Provenge®)
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Known malignancies other than prostate cancer likely to require treatment within 6 months following registration
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A requirement for systemic immunosuppressive therapy (>10mg Prednisone daily or equivalent)
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A history of allergic reactions attributed to compounds of similar chemical or biologic composition to Sipuleucel-T or GM-CSF
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Any infection requiring antibiotic therapy within 1 week prior to registration
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stephenson's Cancer Center | Oklahoma City | Oklahoma | United States | 73114 |
Sponsors and Collaborators
- University of Oklahoma
- Dendreon
Investigators
- Principal Investigator: Kelly Stratton, MD, Investigator
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OU-SCC-EXCITE