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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)


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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)


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the immune response generated by sipuleucel-T

Outcome Description:

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)

Outcome Time Frame:

Change in immune response from Baseline through Month 12

Safety Issue:

No

Principal Investigator

Robert Sims, MD

Investigator Role:

Study Director

Investigator Affiliation:

Dendreon

Authority:

United States: Food and Drug Administration

Study ID:

P10-1

NCT ID:

NCT01338012

Start Date:

November 2011

Completion Date:

Related Keywords:

  • Prostate Cancer
  • metastatic castrate resistant prostate cancer
  • prostate cancer
  • prostate
  • immune therapy
  • immunotherapy
  • vaccine
  • dendritic cells
  • antigen-presenting cells
  • antigen presenting cells
  • cancer vaccine
  • PSA
  • prostatic adenocarcinoma
  • Prostatic Neoplasms

Name

Location

University of Colorado Cancer Center Denver, Colorado  80262
Virginia Mason Medical Center Seattle, Washington  98111
Oregon Health & Science University Portland, Oregon  97201
South Orange County Medical Research Center Laguna Hills, California  92653
Urology of Virginia Newport News, Virginia  23606
Virginia Mason Hospital Seattle, Washington  98101