Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer (CRPC) Patients Previously Treated on Dendreon Study P-11 (NCT00779402)

This study is currently recruiting participants.
Verified October 2013 by Dendreon
Sponsor:
Information provided by (Responsible Party):
Dendreon
ClinicalTrials.gov Identifier:
NCT01338012
First received: March 2, 2011
Last updated: October 9, 2013
Last verified: October 2013

March 2, 2011
October 9, 2013
November 2011
March 2017   (final data collection date for primary outcome measure)
To evaluate the immune response generated by sipuleucel-T [ Time Frame: Change in immune response from Baseline through Month 12 ] [ Designated as safety issue: No ]
Antigen-specific T cell responses will be assessed by mean of a proliferation assay and an interferon-gamma enzyme-linked immunospot (ELISPOT) assay. Antigen-specific humoral immune responses will be measured by means of an enzyme-linked immunosorbent assay (ELISA)
To evaluate the immune response generated by sipuleucel-T [ Time Frame: From Baseline through Month 12 ] [ Designated as safety issue: No ]
Antigen-specific T cell responses will be assessed by mean of a proliferation assay and an interferon-gamma enzyme-linked immunospot (ELISPOT) assay. Antigen-specific humoral immune responses will be measured by means of an enzyme-linked immunosorbent assay (ELISA)
Complete list of historical versions of study NCT01338012 on ClinicalTrials.gov Archive Site
  • To evaluate the safety of sipuleucel-T [ Time Frame: Baseline to study completion ] [ Designated as safety issue: Yes ]
    Safety will be assessed by summarizing adverse events, laboratory evaluations, vital signs, and physical examination findings.
  • To explore the correlation between sipuleucel-T immune response and overall survival. [ Time Frame: Baseline to study completion ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer (CRPC) Patients Previously Treated on Dendreon Study P-11 (NCT00779402)
An Open-Label Multicenter Study of Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer Patients Previously Treated With Sipuleucel-T on Dendreon Study P-11 (NCT00779402)

This study is being conducted to examine the immune response generated by sipuleucel-T in subjects previously treated with sipuleucel-T in the androgen dependent setting. The study will also assess the safety of receiving up to 3 additional infusions of sipuleucel-T. This is an open-label, uncontrolled, multicenter study, conducted in up to 14 clinical trial sites. The anticipated duration of the study is approximately 6 years.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Drug: sipuleucel-T
Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
Other Name: PROVENGE, APC8015
Experimental: sipuleucel-T
Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
Intervention: Drug: sipuleucel-T
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
Not Provided
March 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Previously randomized in Dendreon's P-11 study (NCT00779402) and received at least one infusion of sipuleucel-T
  • Radiologic evidence of metastasis
  • Castrate resistant prostate cancer. Subjects must have current or historical evidence of disease progression concomitant with surgical or medical castration, as demonstrated by PSA progression OR progression of measurable disease OR progression of non-measurable disease
  • Castrate level of testosterone (< 50 ng/dL) achieved via medical or surgical castration
  • Adequate hematologic function

Exclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status > 2
  • Treatment with chemotherapy within 3 months prior to registration
  • Treatment with systemic corticosteroids, external beam radiation therapy, or any investigational product for prostate cancer within 28 days prior to registration
  • Current or imminent pathologic long-bone fracture
  • Known malignancies other than prostate cancer that are likely to require treatment within 6 months following 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 GM-CSF
  • Any infection requiring antibiotic therapy or causing fever within 1 week prior to registration
  • Any surgery requiring general anesthetic within 28 days prior to registration
Male
18 Years and older
No
Not Provided
United States
 
NCT01338012
P10-1
Not Provided
Dendreon
Dendreon
Not Provided
Study Director: Robert Sims, MD Dendreon
Dendreon
October 2013

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