S0354, Anti-IL-6 Chimeric Monoclonal Antibody in Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: CNTO 328
Intervention MeSH terms: Siltuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the prostate; stage IV prostate cancer; recurrent prostate cancer

Summary:

      RATIONALE: Monoclonal antibodies, such as anti-IL-6 chimeric monoclonal antibody, can block
      tumor growth in different ways. Some block the ability of tumor cells to grow and spread.
      Others find tumor cells and help kill them or carry tumor-killing substances to them.

      PURPOSE: This phase II trial is studying how well anti-IL-6 chimeric monoclonal antibody
      works in treating patients with metastatic prostate cancer that did not respond to hormone
      therapy.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed adenocarcinoma of the prostate

               -  Metastatic disease (N1 and/or M1)

          -  Disease unresponsive or refractory to androgen-deprivation therapy

          -  Must have received only 1 prior chemotherapy regimen comprising a taxane OR
             mitoxantrone

          -  Disease progression as defined by one or more of the following:

               -  Progression of measurable disease

                    -  Prior radiotherapy allowed provided radiotherapy was completed ≥ 2 months
                       ago and lesion progressed since radiotherapy

               -  Progression of nonmeasurable disease

                    -  Prior radiotherapy within the past 2 months allowed, but disease is
                       considered nonmeasurable

               -  Rising prostate-specific antigen (PSA) after > 2 courses of chemotherapy OR
                  within 6 months of last chemotherapy dose

                    -  Rising PSA defined as at least 2 consecutive rises in PSA to be documented
                       over a reference value (measure 1)

          -  PSA ≥ 5 ng/mL

          -  Surgical or medical castration required

               -  Castration using luteinizing hormone-releasing hormone agonist (leuprolide
                  acetate or goserelin) or antagonist (abarelix) should not be interrupted

          -  No history of brain metastases OR currently treated or untreated brain metastases

               -  Patients with clinical suspicion of brain metastases must have a brain CT scan or
                  MRI negative for metastatic disease within the past 56 days

        PATIENT CHARACTERISTICS:

          -  Zubrod performance status 0-2

          -  Fertile patients must use effective contraception

          -  Absolute granulocyte count ≥ 1,500/mm³ (transfusion independent)

          -  Platelet count ≥ 100,000/mm³ (transfusion independent)

          -  Hemoglobin ≥ 9 g/dL (transfusion independent)

          -  Creatinine clearance ≥ 40 mL/min

          -  Bilirubin ≤ 2 times upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST) ≤ 2 times ULN

          -  No uncontrolled intercurrent illnesses including, but not limited to, the following:

               -  Diabetes mellitus

               -  Ongoing or active infection

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Cardiac arrhythmia

          -  No psychiatric illness or social situation that would preclude study compliance

          -  No known HIV positivity

          -  No other prior malignancy except for the following:

               -  Adequately treated basal cell or squamous cell skin cancer

               -  Adequately treated stage I or II cancer in complete remission

               -  Any other cancer from which the patient has been disease-free for 5 years

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  At least 21 days since prior surgery and recovered

          -  At least 28 days since prior chemotherapy and recovered

          -  At least 28 days since prior flutamide or ketoconazole

          -  At least 28 days since prior radiotherapy (to < 30% of the bone marrow only) and
             recovered

               -  Prior samarium Sm 153 lexidronam pentasodium allowed

               -  No prior strontium chloride Sr 89

          -  At least 42 days since prior bicalutamide or nilutamide

          -  More than 60 days since prior murine or chimeric proteins or human/murine monoclonal
             antibody

          -  Concurrent bisphosphonate therapy allowed provided the following are true:

               -  Therapy commenced at least 3 weeks ago

               -  Therapy continues for the entire duration of study treatment

          -  No other concurrent anticancer therapy, including cytotoxic therapy, biologic therapy,
             radiotherapy, or hormonal therapy (except for luteinizing hormone-releasing hormone
             agonist or antagonist in patients who have not had an orchiectomy)