Concurrent Versus Sequential Treatment With Sipuleucel-T and Abiraterone in Men With Metastatic Castrate Resistant Prostate Cancer (mCRPC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dendreon
ClinicalTrials.gov Identifier:
NCT01487863
First received: December 6, 2011
Last updated: February 20, 2014
Last verified: February 2013
  Purpose

The purpose of this study is to evaluate the impact of concurrent versus sequential administration of abiraterone acetate plus prednisone on product parameters of sipuleucel-T, and to assess the safety and efficacy of sipuleucel-T with concurrent or sequential administration of abiraterone acetate plus prednisone in men with metastatic castrate resistant prostate cancer.


Condition Intervention Phase
Prostate Cancer Metastatic
Hormone Refractory Prostate Cancer
Biological: sipuleucel-T
Drug: abiraterone acetate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Randomized, Open-label, Phase 2 Trial of Sipuleucel-T With Concurrent Versus Sequential Administration of Abiraterone Acetate Plus Prednisone in Men With Metastatic Castrate Resistant Prostate Cancer (mCRPC)

Resource links provided by NLM:


Further study details as provided by Dendreon:

Primary Outcome Measures:
  • Evaluate cumulative sipuleucel-T CD54 upregulation [ Time Frame: Over the course of sipuleucel-T therapy (approximately 1 month) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate sipuleucel-T product parameters [ Time Frame: Over the course of sipuleucel-T therapy (approximately 1 month) ] [ Designated as safety issue: No ]
    To evaluate sipuleucel-T product parameters of cumulative CD54+ cell count and total nucleated cell count

  • Evaluate the peripheral immune response to sipuleucel-T [ Time Frame: From baseline through 26 weeks ] [ Designated as safety issue: No ]
    Peripheral immune responses to sipuleucel-T will be measured, including IFN-gamma production by T cells, T cell proliferation, and antibody production (humoral response) to both PA2024 and PAP

  • Evaluate safety of sipuleucel-T therapy with concurrent or sequential administration of abiraterone acetate plus prednisone [ Time Frame: From registration to 30 days following the last study treatment ] [ Designated as safety issue: Yes ]
    Safety will be assessed by evaluation of adverse events, laboratory tests, vital signs, ECOG performance status, and physical examinations


Estimated Enrollment: 60
Study Start Date: December 2011
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Concurrent Arm
Subjects will receive sipuleucel-T concurrent with abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone treatment will start the next day after the first infusion of sipuleucel-T and continue for 26 weeks or until disease progression, unacceptable toxicity, or death, whichever occurs first.
Biological: 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 Names:
  • PROVENGE(R)
  • APC8015
Drug: abiraterone acetate
Abiraterone acetate (1000 mg po QD) is administered in combination with prednisone (5 mg po BD) for a total of 26 weeks.
Other Name: ZYTIGA(R)
Experimental: Sequential Arm
Subjects will receive sipuleucel-T therapy followed by abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone will start 6 weeks after the last infusion of sipuleucel-T and continue for 26 weeks or until disease progression, unacceptable toxicity, or death, whichever occurs first.
Biological: 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 Names:
  • PROVENGE(R)
  • APC8015
Drug: abiraterone acetate
Abiraterone acetate (1000 mg po QD) is administered in combination with prednisone (5 mg po BD) for a total of 26 weeks.
Other Name: ZYTIGA(R)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • historically documented prostate cancer confirmed by a pathology report from prostate biopsy or radical prostatectomy specimen
  • metastatic status as evidenced by imaging obtained </= 56 days prior to registration demonstrating bone metastasis or lymph node metastasis
  • castrate resistant prostate cancer: castrate levels of testosterone (</= 50 ng/dL; evidence of disease progression concomitant with surgical or medical castration
  • serum PSA >/= 2.0 ng/mL
  • castrate levels of testosterone (</= 50 ng/dL) achieved via medical or surgical castration
  • baseline ECOG performance status of </= 1
  • systolic blood pressure (BP) </= 140 mm HG and diastolic BP </= 90 mm Hg at screening
  • adequate baseline hematologic, renal, and liver functions
  • must live in a permanent residence within a comfortable driving distance (roundtrip within one day) of the clinical trial site

Exclusion Criteria:

  • the presence of known lung, liver, or brain metastases, malignant pleural effusions, or malignant ascites
  • New York Heart Association Class III or IV heart failure
  • any medical condition that may be compromised by increases in blood pressure, hypokalemia, or fluid retention
  • Child-Pugh Class B or C hepatic insufficiency
  • spinal cord compression, imminent long bone fracture, or any other condition likely to require radiation therapy and/or steroids for pain control
  • known adrenalcortical insufficiency
  • any medical contraindications to receiving prednisone
  • prior treatment with sipuleucel-T
  • previous treatment with abiraterone acetate (Zytiga(R)) or ipilimumab (Yervoy(TM))
  • a requirement for systemic immunosuppressive therapy for any reason. Use of inhaled, intra-nasal, intra-articular, and topical steroids is allowed.
  • treatment with any investigational vaccine or immunotherapy
  • a history of stage III or greater cancer, excluding prostate cancer. Basal or squamous cell skin cancers must have been adequately treated and the subject must be disease-free at the time of registration. Subjects with a history of stage I or II cancer must have been adequately treated and been disease-free for ≥ 3 years at the time of registration.
  • myocardial infarction or ventricular or atrial arrhythmia within 6 months prior to registration
  • ongoing anti-androgen withdrawal response.
  • systemic steroid use within ≤ 60 days of registration
  • treatment with denosumab (Xgeva(R) or Prolia (R)) within ≤ 3 months prior to registration
  • positive test for HIV or HTLV infections. Subjects with a positive test for hepatitis B or hepatitis C are allowed provided they meet the LFT criteria and have no signs of acute infection or active disease.
  • treatment with any of the following medications or interventions within 28 days prior to registration: external beam radiation or major surgery requiring general anesthetic; saw palmetto; megestrol acetate (Megace(R)), diethylstilbestrol, and cyproterone; 5-alpha-reductase inhibitors (e.g. finasteride [Proscar(R)], dutasteride [Avodart(R)]); steroidal anti-androgen therapy; any other systemic therapy for prostate cancer, except for medical castration; treatment with any other investigational product for prostate cancer; substrates of CYP2D6 (e.g. including but not limited to thioridazine); inhibitors of CYP3A4 (e.g. including but not limited to ketoconazole, itraconazole, clarithromycin, nefazodone, telithromycin, and voriconazole); inducers of CYP3A4 (e.g. including but not limited to phenytoin, carbamazepine, rifampin, rifapentine, and phenobarbital)
  • a requirement for treatment with opioid analgesics within 21 days prior to registration
  • an active infection or infection requiring parenteral antibiotic therapy or causing fever within 7 days of registration
  • any medical intervention, or other condition, or any other circumstance that, in the opinion of the Investigator or the Dendreon Medical Monitor, could compromise adherence with study requirements or otherwise compromise the study's objectives
  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: NCT01487863

Locations
United States, California
Moores UCSD Cancer Center
La Jolla, California, United States, 92093
UCSD Medical Center - La Jolla
La Jolla, California, United States, 92037
Cancer Center Oncology Medical Group
La Mesa, California, United States, 91942
UCSD Medical Center - Hillcrest
San Diego, California, United States, 92103
Sharp Rees-Stealy
San Diego, California, United States, 92123
Medical Oncology Associates - SD
San Diego, California, United States, 92123
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Colorado
The Urology Center of Colorado
Denver, Colorado, United States, 80211
United States, District of Columbia
Georgetown University Medical Center - Lombardi Cancer Center
Washington, District of Columbia, United States, 20007
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Maryland
Mid Atlantic Urology Associates, Mid Atlantic Clinical Research
Greenbelt, Maryland, United States, 20770
United States, Nebraska
GU Research Center, LLC
Omaha, Nebraska, United States, 68130
United States, New York
The Mount Sinai Medical Center
New York, New York, United States, 10029
NYU Clinical Cancer Center, NYU Langone Medical Center
New York, New York, United States, 10016
Associated Medical Professionals of NY, PLLC
Oneida, New York, United States, 13421
Associated Medical Professionals of New York, PLLC
Syracuse, New York, United States, 13210
United States, Oregon
Providence Cancer Center Oncology and Hematology Care
Portland, Oregon, United States, 97213
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
Urology Associates, P.C.
Nashville, Tennessee, United States, 37209
United States, Virginia
Urology of Virginia
Virginia Beach, Virginia, United States, 23462
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Dendreon
Investigators
Study Director: Andrew C Stubbs, PhD Dendreon
  More Information

No publications provided

Responsible Party: Dendreon
ClinicalTrials.gov Identifier: NCT01487863     History of Changes
Other Study ID Numbers: P11-3
Study First Received: December 6, 2011
Last Updated: February 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Dendreon:
prostate cancer
prostate
AIPC
androgen-independent
androgen independent
hormone insensitive
hormone-insensitive
PSA
prostatic adenocarcinoma
hormone-refractory
hormone refractory
HRPC
immune therapy
immunotherapy
vaccine
dendritic cells
antigen-presenting cells
antigen presenting cells
cancer vaccine
therapeutic vaccine
therapeutic cancer vaccine
recombinant
biological
biopharmaceutical
biotechnology
biotech

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Prednisone
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014