monoclonal antibody therapy in treating patients with prostate cancer

Conditions: Prostate Cancer

Summary: rationale: monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. purpose: phase ii trial to study the effectiveness of monoclonal antibody therapy in treating patients who have prostate cancer that has not responded to hormone therapy.

objectives: * determine the antitumor effects of monoclonal antibody huj591 in patients with progressive androgen-independent prostate cancer. * determine the biodistribution and dosimetry of this antibody in these patients. * determine the effect on biodistribution of the delivery sequence of unlabeled vs indium in 111-labeled antibody in these patients. * determine the haha response in patients treated with this regimen. * correlate the dose of monoclonal antibody huj591 with antibody-dependent cellular cytotoxicity in these patients. outline: patients are assigned to one of two treatment groups. * group i: patients receive monoclonal antibody huj591 iv followed by indium in 111 monoclonal antibody huj591 on day 1. * group ii: patients receive monoclonal antibody huj591 concurrently with indium in 111 monoclonal antibody huj591 as in group i. treatment in both groups repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. patients are followed for 4 weeks and then monthly for 3 months. projected accrual: a total of 14 patients (7 per treatment group) will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed prostate cancer * disease progression after prior castration * at least 3 rising psa levels at least 1 week apart or 2 rising levels at least 4 weeks apart * new osseous lesions on bone scan and/or more than 25% increase in bidimensionally measurable soft tissue disease or appearance of new sites of disease by ct scan or mri * testosterone no greater than 50 ng/ml * medical therapy (e.g., gonadotropin-releasing hormone analogues) to maintain castrate level of testosterone should continue in the absence of surgical orchiectomy * progression of disease after discontinuation of prior anti-androgen therapy * no requirement for palliative therapy within the past 12 weeks * no active cns or epidural primary tumor or active cns or epidural metastases patient characteristics: age: * 18 and over performance status: * karnofsky 60-100% life expectancy: * not specified hematopoietic: * wbc greater than 3,500/mm3 * platelet count greater than 100,000/mm3 hepatic: * bilirubin less than 1.5 mg/dl * gamma-glutamyl-transferase less than upper limit of normal (uln) * ast less than uln * pt less than 14 seconds * no prior autoimmune hepatitis renal: * creatinine less than 1.5 mg/dl or * creatinine clearance greater than 60 ml/min cardiovascular: * no clinically significant cardiac disease (new york heart association class iii or iv) pulmonary: * no severe debilitating pulmonary disease other: * fertile patients must use effective contraception * no active uncontrolled infection or infection requiring iv antibiotics * no prior autoimmune disease prior concurrent therapy: biologic therapy: * no prior murine protein for diagnostic or therapeutic purposes * no other concurrent anticancer immunotherapy chemotherapy: * at least 4 weeks since prior chemotherapy and recovered * no concurrent anticancer chemotherapy endocrine therapy: * see disease characteristics * no concurrent anticancer hormonal therapy radiotherapy: * at least 4 weeks since prior radiotherapy and recovered * concurrent radiotherapy to localized sites of disease (e.g., bone) allowed if the site does not contain sole measurable lesion surgery: * see disease characteristics * no concurrent surgery other: * recovered from all prior therapy * at least 4 weeks since prior therapeutic investigational anticancer drugs * at least 4 weeks since prior participation in therapeutic clinical trial with an experimental drug * no prior diagnostic prostascint, myoscint, or oncoscint scans * no other concurrent therapeutic investigational anticancer agents * no concurrent participation in other therapeutic clinical trial with an experimental drug

Keywords: stage iv prostate cancer recurrent prostate cancer