Sipuleucel-T Manufacturing Demonstration Study

NCT01477749 | Completed Phase 2 Results

• 2 other identifiers: P11-12011-001192-39
• Study Type: interventional
• Target: 47
• Locations: 4 countries
• Sites: 4

Brief Summary

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

Conditions

Cancer of Prostate; Cancer of the Prostate; Neoplasms, Prostate; Neoplasms, Prostatic; Prostate Cancer; Prostate Neoplasms; Prostatic Cancer

Keywords

prostate cancer; prostate; immune therapy; immunotherapy; vaccine; dendritic cells; antigen-presenting cells; antigen presenting cells; cancer vaccine; PSA; prostatic adenocarcinoma

Outcome Measures

Primary Outcomes (4)

• Cumulative CD54+ Cell Count

  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

  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)

• Cumulative CD54 Upregulation

  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.

  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)

• Cumulative Total Nucleated Cell (TNC) Count

  Descriptive summarization of the cumulative sum of TNC counts across infusions

  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)

• Product Viability (Percentage)

  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.

  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)

Study Arms (1)

sipuleucel-T

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.

Biological: sipuleucel-T

Interventions

sipuleucel-T BIOLOGICAL

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.

Also known as: PROVENGE, APC8015

sipuleucel-T

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dendreon: lead

Study Sites (4)

Ludwig Boltzmann-Institute for Applied Cancer Research

Vienna, A-1100, Austria

Location

Department of Cancer Medicine and Genitourinary Oncology Group Institut Gustave Roussy (IGR) Département de médicine

Vaillant, Villejuif Cedex, 94805, France

Location

Radboud University Nijmegen; UMC St Radboud Hospital; Faculteit der Medische Wetenschappen, Urologie

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

Barts Cancer Institute - a Cancer Research UK Centre of Excellence, Queen Mary University of London

London, EC1M 6BQ, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

sipuleucel-T

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Lynn Ngo
• Organization: Dendreon Pharmaceuticals, Inc.

lngo@dendreon.com

206-274-6763

Study Officials

• Andrew Stubbs, PhD

  Dendreon

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2011
• First Posted: November 23, 2011
• Study Start: June 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: December 9, 2015
• Results First Posted: December 9, 2015

Record last verified: 2015-11

Locations

AU (1); FR (1); NL (1); GB (1)