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Sipuleucel-T Manufacturing Demonstration Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dendreon
ClinicalTrials.gov Identifier:
NCT01477749
First received: November 19, 2011
Last updated: November 4, 2015
Last verified: November 2015

November 19, 2011
November 4, 2015
June 2012
June 2014   (final data collection date for primary outcome measure)
  • Cumulative CD54+ Cell Count [ Time Frame: Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively) ] [ Designated as safety issue: No ]

    Descriptive summarization of the cumulative sum of CD54+ counts across infusions.

    Cumulative CD54 upregulation = CD54 upregulation for infusion 1 + CD54 upregulation for infusion 2 + CD54 upregulation for infusion 3

  • Cumulative CD54 Upregulation [ Time Frame: Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively) ] [ Designated as safety issue: No ]
    The increase in surface CD54 on APCs, expressed as an upregulation ratio of the average number of molecules on post-culture versus pre-culture cells. Cumulative CD54 upregulation = CD54 upregulation ratio for infusion 1 + CD54 upregulation ratio for infusion 2 + CD54 upregulation ratio for infusion 3.
  • Cumulative Total Nucleated Cell (TNC) Count [ Time Frame: Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively) ] [ Designated as safety issue: No ]
    Descriptive summarization of the cumulative sum of TNC counts across infusions
  • Product Viability (Percentage) [ Time Frame: Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively) ] [ Designated as safety issue: No ]
    Product viability was measured as the percentage of live PBMC in final product for infusion 1, 2, and 3 as measured by a trypan blue assay and are reported for each final product for infusion 1, 2, and 3.
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 ] [ Designated as safety issue: No ]

Key product parameters are measured with each product manufactured and will be summarized:

  • CD54+ cell count
  • cumulative CD54 upregulation
  • cumulative total nucleated cell (TNC) count
  • product viability (percentage)
Complete list of historical versions of study NCT01477749 on ClinicalTrials.gov Archive Site
Not Provided
Evaluation of the safety of sipuleucel-T manufactured at a European manufacturing facility. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Safety will be assessed by collecting adverse events, laboratory samples, vital signs, ECOG performance status, and physical examinations.
Not Provided
Not Provided
 
Sipuleucel-T Manufacturing Demonstration Study
An Open-Label Study Study of Sipuleucel-T in European Men With Metastatic, Castrate Resistant Prostate Cancer
To demonstrate that sipuleucel-T can be successfully manufactured for subjects with metastatic castrate resistant prostate cancer (mCRPC) at a European manufacturing facility.

This was an open-label, uncontrolled, multi-center study. Study participants will underwent screening procedures to ensure that they met the inclusion and exclusion criteria. Subjects underwent a standard 1.5 to 2.0 blood volume leukapheresis, followed approximately 3 days later by an infusion of sipuleucel-T. This process was be repeated at approximately 2-week intervals for a total of 3 infusions.

In Austria, The Netherlands, and France, a study completion visit occurred between 30 and 37 days post-final infusion, or between 30 and 37 days post-final leukapheresis for subjects not receiving at least 1 infusion. In the UK, a follow-up visit occurred 30 days after the subject's final infusion and a study completion visit occurred 6 months after the subject's final infusion.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
  • Cancer of Prostate
  • Cancer of the Prostate
  • Neoplasms, Prostate
  • Neoplasms, Prostatic
  • Prostate Cancer
  • Prostate Neoplasms
  • Prostatic Cancer
Biological: sipuleucel-T
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.
Other Names:
  • PROVENGE
  • APC8015
Experimental: sipuleucel-T
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.
Intervention: Biological: sipuleucel-T
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
June 2014
June 2014   (final data collection date for primary outcome measure)

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.
Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   France,   Netherlands,   United Kingdom
 
NCT01477749
P11-1, 2011-001192-39
No
Not Provided
Not Provided
Dendreon
Dendreon
Not Provided
Study Director: Andrew Stubbs, PhD Dendreon
Dendreon
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP