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

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Drug: sipuleucel-T	Phase 2


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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)

Resource links provided by NLM:

Genetics Home Reference related topics: prostate cancer

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Sipuleucel-T

U.S. FDA Resources

Further study details as provided by Dendreon:

Primary Outcome Measures:

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)

Secondary Outcome Measures:

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 ]


Enrollment:	8
Study Start Date:	November 2011
Study Completion Date:	April 2015
Primary Completion Date:	April 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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).	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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01338012

Locations


United States, California
Orange County Urology Associates
Laguna Hills, California, United States, 92653
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Washington
Virginia Mason Hospital
Seattle, Washington, United States, 98101
Virginia Mason Medical Center
Seattle, Washington, United States, 98101

Sponsors and Collaborators

Dendreon

Investigators


Study Director:	Robert Israel, MD	Valeant Pharmaceuticals North America LLC

More Information


Responsible Party:	Dendreon
ClinicalTrials.gov Identifier:	NCT01338012 History of Changes
Other Study ID Numbers:	P10-1
Study First Received:	March 2, 2011
Last Updated:	February 29, 2016
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dendreon:


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

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 23, 2016