Status:
COMPLETED
Open Label Study of Sipuleucel-T in Metastatic Prostate Cancer
Lead Sponsor:
Dendreon
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
This is a Multicenter, Open Label, Phase 2 Study of Sipuleucel-T in Men with Metastatic Castrate Resistant Prostate Cancer (CRPC).
Detailed Description
Subjects received sipuleucel-T at 2-week intervals, for a total of 3 infusions. The study evaluated the safety and magnitude of the immune responses to treatment with sipuleucel-T. All subjects were f...
Eligibility Criteria
Inclusion
- Histologically documented adenocarcinoma of the prostate
- Metastatic disease
- Castrate resistant prostate cancer
- Castrate level of testosterone (\< 50 ng/dL) achieved via medical or surgical castration
- Life expectancy of ≥ 3 months
- Men ≥ 18 years of age
- Adequate hematologic, renal and liver function
Exclusion
- Presence of known lung, liver, or brain metastases
- Evidence of neuroendocrine or small cell features
- Eastern Cooperative Oncology Group (ECOG) performance status \> 2
- Prior treatment with 3 infusions of sipuleucel-T (infusions of APC8015F are not exclusionary)
- Imminent pathologic long-bone fracture (cortical erosion on radiography \> 50%) or spinal cord compression
- Known malignancies other than prostate cancer that are likely to require treatment within six months of registration
- A requirement for systemic immunosuppressive therapy for any reason
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to Sipuleucel-T or granulocyte-macrophage colony-stimulating factor
- Any infection requiring parenteral antibiotic therapy or causing fever (temp \> 100.5F or \> 38.1C) within 1 week prior to registration
- Any medical intervention or other condition which, in the opinion of the Principal Investigator or the Dendreon Medical Monitor, could compromise adherence with study requirements or otherwise compromise the study's objectives
- Treatment with any of the following medications or interventions within 28 days of registration:
- Systemic corticosteroids. Use of inhaled, intranasal, intra-articular, and topical steroids is acceptable, as is a short course (ie, ≤ 1 day) of corticosteroids to prevent a reaction to the IV contrast used for CT scans
- Non-steroidal anti-androgens (eg, bicalutamide, flutamide, or nilutamide)
- External beam radiation therapy or major surgery requiring general anesthetic
- Any other systemic therapy for prostate cancer including secondary hormonal therapies, such as megestrol acetate (Megace®), diethylstilbestrol (DES), and ketoconazole. Medical castration therapy is not exclusionary
- Chemotherapy
- Treatment with any other investigational product
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT00901342
Start Date
October 1 2009
End Date
June 1 2015
Last Update
May 23 2017
Active Locations (18)
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1
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
2
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
3
Oncology Specialists, S.C.
Park Ridge, Illinois, United States, 60068
4
Indiana University Department of Urology
Indianapolis, Indiana, United States, 46202