Overview

This trial is active, not recruiting.

Conditions cancer of prostate, cancer of the prostate, neoplasms, prostate, neoplasms, prostatic, prostate cancer, prostate neoplasms, prostatic cancer
Treatment sipuleucel-t
Phase phase 2
Sponsor Dendreon
Start date June 2012
End date January 2015
Trial size 45 participants
Trial identifier NCT01477749, 2011-001192-39, P11-1

Summary

To demonstrate that sipuleucel-T can be successfully manufactured for subjects with metastatic castrate resistant prostate cancer (mCRPC) at a European manufacturing facility.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Arm
(Experimental)
Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
sipuleucel-t PROVENGE
Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.

Primary Outcomes

Measure
A descriptive summarization of key product parameters for sipuleucel-T produced at a European manufacturing facility.
time frame: Approximately 1 month from first product manufactured

Secondary Outcomes

Measure
Evaluation of the safety of sipuleucel-T manufactured at a European manufacturing facility.
time frame: 9 months

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - Histologically documented adenocarcinoma of the prostate - Metastatic disease as evidenced by soft tissue and/or bony metastases on bone scan and/or computed tomography (CT) scan of the abdomen and pelvis at any time prior to registration - Castrate resistant prostate cancer - Serum PSA ≤ 5.0 ng/mL - Castration levels of testosterone (≤ 50 ng/dL; ≤ 1.74 nmol/L) achieved via medical or surgical castration. Surgical castration must have occurred at least 3 months prior to registration. - ECOG performance status ≤ 1 - Adequate hematologic, renal, and liver function - Negative serology tests indicating no active infection with human immunodeficiency virus types 1 and 2 (HIV-1/2), human T cell lymphotropic virus types 1 and 2 (HTLV-I/II), and Hepatitis B and C viruses. Exclusion Criteria: - The presence of known brain metastases - A requirement for systemic immunosuppressive therapy for any reason - Treatment with any investigational vaccine within 2 years prior to registration - Any previous treatment with sipuleucel-T - Any previous treatment with ipilimumab (Yervoy[TM], MDX-010, or MDX-101) or denosumab (Xgeva[TM]) - Pathologic long-bone fractures, 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 6 months of registration - A history of allergic reactions attributed to compounds of similar chemical or biologic composition to sipuleucel-T or GM-CSF - More than 2 chemotherapy regimens at any time prior to registration - Treatment with any chemotherapy within 90 days of registration - Received granulocyte colony-stimulating factor (G-CSF) or GM-CSF within 90 days prior to registration - 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 (i.e., ≤ 1 day) of corticosteroids to prevent a reaction to the IV contrast used for CT scans. - Non-steroidal anti-androgens (e.g., 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. - Immunosuppressive therapy - Treatment with any other investigational product - Any infection requiring parenteral antibiotic therapy or causing fever (temperature > 100.5°F or 38.1°C) within 7 days prior to registration. - Any medical intervention or other condition which, in the opinion of the Investigator or the Dendreon Medical Monitor, could compromise adherence with study requirements or otherwise compromise the study's objectives.

Additional Information

Official title An Open-Label Study Study of Sipuleucel-T in European Men With Metastatic, Castrate Resistant Prostate Cancer
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Dendreon.