A Phase II Study of CNTO 328, A Monoclonal Antibody Against Interleukin-6 (IL-6), in Patients With Hormone Refractory Prostate Cancer
A Phase II Study of CNTO 328, A Monoclonal Antibody Against Interleukin-6 (IL-6), in Patients With Hormone Refractory Prostate Cancer
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.
OBJECTIVES:
Primary
Secondary
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.
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
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
Progression of nonmeasurable disease
Rising prostate-specific antigen (PSA) after > 2 courses of chemotherapy OR within 6 months of last chemotherapy dose
PSA ≥ 5 ng/mL
Surgical or medical castration required
No history of brain metastases OR currently treated or untreated brain metastases
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:
No psychiatric illness or social situation that would preclude study compliance
No known HIV positivity
No other prior malignancy except for the following:
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
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:
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)
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