To Evaluate Sipuleucel-T Manufactured With Different Concentrations of (PA2024) Antigen

NCT ID: NCT00715078

Last Updated: 2017-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2015-05-31

Brief Summary

This is a randomized, multicenter, single blind, Phase 2 trial of immunotherapy in men with metastatic androgen independent prostate cancer to evaluate sipuleucel-T manufactured with different concentrations of PA2024 antigen

Detailed Description

This is a randomized, multicenter, single blind, Phase 2 trial of immunotherapy in men with metastatic androgen independent prostate cancer to evaluate sipuleucel-T manufactured with 1 of 3 different concentrations of PA2024 antigen The primary purpose of this study is to compare the changes in CD54 upregulation between each of these 3 groups of subjects.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cohort A

Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10\^7 peripheral blood mononuclear cells (PBMCs) per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.

Group Type: ACTIVE_COMPARATOR

sipuleucel-T

Intervention Type: BIOLOGICAL

Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF)

Cohort B

Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10\^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.

Group Type: ACTIVE_COMPARATOR

sipuleucel-T

Intervention Type: BIOLOGICAL

Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF)

Cohort C

Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10\^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.

Group Type: ACTIVE_COMPARATOR

sipuleucel-T

Intervention Type: BIOLOGICAL

Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF)

Interventions

sipuleucel-T

Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF)

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

For a subject to be eligible for participation in this study, all of the following criteria must be satisfied.

• Histologically documented adenocarcinoma of the prostate.
• Metastatic disease.
• Progressive androgen independent castrate resistant prostate cancer.
• Serum PSA ≥ 5.0 ng/mL.
• Life expectancy of ≥ 6 months.
• Castrate level of testosterone (< 50 ng/dL) achieved via medical or surgical castration.
• Men ≥ 18 years of age.
• Adequate hematologic, renal and liver function.

Exclusion Criteria

A subject will not be eligible for participation in this study if any of the following criteria apply.

• The presence of known lung, liver, or brain metastases, malignant pleural effusions, or malignant ascites.
• A requirement for treatment with opioid analgesics for any reason within 21 days prior to registration.
• Moderate to severe disease related pain.
• Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2.
• Use of non-steroidal antiandrogens within 6 weeks of registration.
• Anti-androgen withdrawal response.
• Treatment with chemotherapy within 3 months of registration.
• More than 2 chemotherapy regimens prior to registration.
• Initiation or discontinuation of bisphosphonate therapy within 28 days prior to registration.
• Treatment with any of the following medications or interventions within 28 days of registration:

• Systemic corticosteroids,
• External beam radiation therapy or surgery,
• Dietary and herbal supplements, as well as alternative treatments that have evidence of hormonal and/or anticancer properties (e.g., prostate cancer (PC) -SPES or PC-SPEC) and saw palmetto,
• Megestrol acetate (Megace®), diethylstilbesterol (DES), or cyproterone acetate, ++Ketoconazole,
• 5-alpha-reductase inhibitors,
• High dose calcitriol [1,25(OH)2Vitamin D] (i.e., > 0.5 mcg/day).
• Any other systemic therapy for prostate cancer (except for medical castration).
• Treatment with any investigational vaccine within 2 years of registration or treatment with any other investigational product within 28 days of registration.
• Participation in any previous study involving sipuleucel-T, regardless of whether the subject received sipuleucel-T (APC8015) or placebo.
• Known pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography > 50%) or spinal cord compression.
• 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.
• 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 granulocyte-macrophage colony-stimulating factor.
• Any infection requiring parenteral antibiotic therapy or causing fever (temp > 100.5°F or > 38.1°C) within 1 week prior to registration.
• Any medical intervention or other condition which, in the opinion of the Principal Investigator or the Dendreon Medical Monitor, could compromise adherence with study requirements or otherwise compromise the study's objectives.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Dendreon

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Israel, MD

Role: STUDY_DIRECTOR

Valeant Pharmaceuticals North America LLC

Locations

UCSD Moores Cancer Center

La Jolla, California, United States

Sharp Clinical Oncology Research

San Diego, California, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Indiana University

Indianapolis, Indiana, United States

Mount Sinai School of Medicine

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Providence Medical Center

Portland, Oregon, United States

Kaiser Permanente

Portland, Oregon, United States

Northwest Cancer Specialists

Portland, Oregon, United States

Urology of Virginia, Sentara Medical Group

Norfolk, Virginia, United States

Virginia Mason Medical Center Urology and Renal Transplantation

Seattle, Washington, United States

Seattle Cancer Care Alliance

Seattle, Washington, United States

Countries

United States

Related Links

http://www.naspcc.org

National Alliance of State Prostate Cancer Coalitions

http://www.ustoo.org

Us TOO International

Other Identifiers

P07-2

Identifier Type: -

Identifier Source: org_study_id