A Safety and Efficacy Study of Siltuximab (CNTO 328) in Male Subjects With Metastatic Hormone-Refractory Prostate Cancer (HRPC)
Condition: Cancer, Prostate
MeSH terms: Prostatic Neoplasms
Intervention: Mitoxantrone; Siltuximab; Prednisone
Intervention description: Mitoxantrone 12 mg/m^2 intravenously as a 30 minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2); Siltuximab 6 mg/kg intravenously as a 2 hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; Prednisone 5 mg orally twice daily
Intervention MeSH terms: Prednisone; Mitoxantrone; Siltuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 106.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer; Prostate; IL-6; Mitoxantrone; Metastatic prostate cancer

Summary:

      The purpose of this study is to assess the safety and efficacy of siltuximab administered in
      combination with mitoxantrone and prednisone in participants with metastatic (spread of
      cancer cells from one part of the body to another) hormone-refractory (not responding to
      treatment) prostate cancer (abnormal tissue that grows and spreads in the body) (HRPC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically (the study of tissue under the microscope) or cytologically (the study
             of cells) confirmed adenocarcinoma (a malignant epithelial tumor with a glandular
             organization) of the prostate

          -  Radiologically (Gamma and Computed Topography [CT] scans) documented metastatic
             disease

          -  At least 6 weeks of treatment with 1 prior docetaxel-based chemotherapy for metastatic
             Hormone Refractory Prostate Cancer (HRPC)

          -  Disease progression, during or within 6 months of stopping of prior docetaxel-based
             therapy, based on one of the following: serum Prostate Specific Antigen (PSA)
             progression, defined as a rise in at least 2 consecutive serum PSA values, each
             obtained at least 1 week apart or radiologic disease progression: if disease
             progression is shown by bone scan only, then disease progression is defined by the
             appearance of 2 or more new bone lesions (abnormal area of tissue, such as a wound,
             sore, rash, or boil)

          -  Orchiectomy (surgery to remove one or both testicles) or testosterone less than 50
             nanogram per decilliter (ng/dL) by means of pharmacological/chemical castration

        Exclusion Criteria:

          -  No evidence of a brain tumor

          -  No more than 1 line of chemotherapy for metastatic prostate cancer

          -  No prior mitoxantrone treatment

          -  Prior malignancy (other than prostate cancer) except adequately treated superficial
             bladder cancer, basal cell or squamous cell carcinoma (type of cancer) of the skin, or
             other cancer for which the subject has been disease-free for atleast 3 years

          -  No Human Immunodeficiency Virus (HIV) (a life-threatening infection that you can get
             from an infected person's blood or from having sex with an infected person)
             seropositivity or hepatitis (inflammation of the liver) B or C infection