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| Name | Class |
|---|---|
| Dendreon | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extended course of Sipuleucel-T treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sipuleucel-T | Biological | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients completing 3 doses of Sipuleucel-T immunotherapy. | 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. | up to 5 months |
| 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. | 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. | up to 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the mean difference in immune response to Sipuleucel-T treatment among different racial groups. | 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. | up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
The study is focused on a prostate cancer-specific group.
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| Name | Affiliation | Role |
|---|---|---|
| Kelly Stratton, MD | Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oklahoma Health Sciences Center, Stephenson Cancer Center | Oklahoma City | Oklahoma | 73114 | United States |
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| ID | Term |
|---|---|
| C511774 | sipuleucel-T |
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The primary objective is to evaluate the feasibility and immune response of an extended course of Sipuleucel-T immunotherapy given at week 0, 2, and 12-14 in patients with metastatic castration-resistant prostate cancer.
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| Evaluate the potential tumor response based on the changes in serum PSA at baseline and within 30 days of last dose. |
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. |
| up to 12 Months |