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Sipuleucel-T Manufacturing Demonstration Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dendreon
ClinicalTrials.gov Identifier:
NCT01477749
First received: November 19, 2011
Last updated: April 24, 2014
Last verified: March 2013

November 19, 2011
April 24, 2014
June 2012
January 2015   (final data collection date for primary outcome 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 ] [ 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)
Same as current
Complete list of historical versions of study NCT01477749 on ClinicalTrials.gov Archive Site
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.
Same as current
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.

Not Provided
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.
 
Active, not recruiting
45
January 2015
January 2015   (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
No
Contact information is only displayed when the study is recruiting subjects
Austria,   France,   Netherlands,   United Kingdom
 
NCT01477749
P11-1, 2011-001192-39
No
Dendreon
Dendreon
Not Provided
Study Director: Andrew Stubbs, PhD Dendreon
Dendreon
March 2013

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