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

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

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

Key facts

Study ID

NCT00715078

Run by

Dendreon

People needed

122

Starts

2008-10-01

Expected to finish

2015-05-01

Last updated by the study team

2017-05-23

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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