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A Phase II Study of CNTO 328, A Monoclonal Antibody Against Interleukin-6 (IL-6), in Patients With Hormone Refractory Prostate Cancer

Description

OBJECTIVES: Primary - Assess the confirmed prostate-specific antigen response in patients with hormone-refractory metastatic prostate cancer treated with anti-IL-6 chimeric monoclonal antibody. Secondary - Assess overall survival and progression-free survival of these patients. - Assess the objective response rate (confirmed and unconfirmed, complete and partial response) in patients with measurable disease treated with this regimen. - Assess the qualitative and quantitative toxicities of this regimen. OUTLINE: This is an open-label, multicenter study. Patients receive anti-IL-6 chimeric monoclonal antibody IV over 2 hours on day 1. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for up to 2 years. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Phase

N/A

Inclusion and Exclusion Criteria

  • 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)

Sites

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