radiolabeled monoclonal antibody in treating patients with progressive metastatic androgen-independent adenocarcinoma (cancer) of the prostate

Conditions: Prostate Cancer

Summary: rationale: radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver radioactive tumor-killing substances to them without harming normal cells. purpose: this phase ii trial is studying how well radiolabeled monoclonal antibody works in treating patients with progressive metastatic androgen-independent adenocarcinoma (cancer) of the prostate.

objectives: primary * determine the prostate-specific antigen (psa) response rate in patients with progressive metastatic androgen-independent adenocarcinoma of the prostate treated with lutetium lu 177 monoclonal antibody j591. * determine the measurable disease response rate in patients treated with this drug. secondary * determine the toxicity of this drug in these patients. * determine the duration of biochemical psa and/or measurable disease response in patients treated with this drug. * determine the incidence of human anti-j591 antibody (haha) response in patients treated with this drug. * correlate hematological toxicity of this drug with bone marrow involvement (bone scan index) in these patients. * determine the survival rate in patients treated with this drug. * determine the targeting of this drug to known tumor sites in these patients. * determine the tumor-absorbed radiation dose in patients treated with this drug. outline: this is a multicenter, open-label study. patients receive a single dose of lutetium lu 177 monoclonal antibody j591 iv on day 1. patients then undergo radionuclide scanning between days 6-8 to confirm tumor targeting by the study drug. patients are followed every 3 months. projected accrual: a total of 17-32 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed adenocarcinoma of the prostate * metastatic disease * progressive disease after prior antiandrogen therapy, as evidenced by at least 1 of the following parameters: * new osseous lesions on bone scan * greater than 25% increase in the sum of the products of the longest perpendicular diameters of the lesions or the appearance of new lesions on mri or ct scan * rising prostate-specific antigen (psa) despite adequate medical or surgical castration therapy * consecutive increase in psa, determined by two separate measurements taken at least 1 week apart and confirmed by a third, and if necessary, a fourth measurement * psa must be ≥ 5 ng/ml and ≥ 25% above the previous nadir * measurable or evaluable disease * serum testosterone ≤ 50 ng/dl * no confluent lesions involving axial and appendicular skeleton on bone scan ("superscan") patient characteristics: age * over 18 performance status * karnofsky 70-100% life expectancy * at least 6 months hematopoietic * absolute neutrophil count ≥ 2,000/mm\^3 * hematocrit ≥ 30% * hemoglobin ≥ 10 g/dl * platelet count ≥ 150,000/mm\^3 * no serious hematologic illness that would preclude study participation hepatic * ast ≤ 2 times upper limit of normal (uln) * bilirubin ≤ 1.5 times uln * ptt normal * pt normal or * inr normal * no serious hepatic illness that would preclude study participation renal * creatinine ≤ 2.5 mg/dl * calcium ≤ 11 mg/dl * no serious renal illness that would preclude study participation cardiovascular * no new york heart association class iii or iv heart disease * no active angina pectoris * no prior deep vein thrombophlebitis within the past 3 months * no other serious cardiac illness that would preclude study participation pulmonary * no pulmonary embolus within the past 3 months * no other serious respiratory illness that would preclude study participation other * fertile patients must use effective contraception * hiv negative * no serious cns illness that would preclude study participation * no active serious infection not controlled by antibiotics * no other serious illness that would preclude study participation prior concurrent therapy: biologic therapy * more than 2 weeks since prior red blood cell or platelet transfusions * more than 2 weeks since prior hematopoietic growth factors * no prior monoclonal antibody therapy except prostascint® * no other concurrent monoclonal antibody-based therapy * no concurrent medication to support platelet count (e.g., oprelvekin) chemotherapy * more than 4 weeks since prior cytotoxic chemotherapy endocrine therapy * see disease characteristics * concurrent luteinizing hormone-releasing hormone (lhrh) analog allowed provided 1 of the following is true: * treatment is maintained during study participation * treatment is terminated at least 10 weeks (for 1-month depot preparations), 24 weeks (for 3-month depot preparations), or 32 weeks (for 4-month depot preparations) prior to study entry * more than 4 weeks since prior corticosteroids * more than 4 weeks since prior adrenal hormone inhibitors * concurrent low-dose prednisone (≤ 5mg/day) for adrenal insufficiency allowed * no concurrent finasteride radiotherapy * more than 4 weeks since prior radiotherapy * no prior radiotherapy to \> 25% of skeleton * no prior strontium chloride sr 89 or samarium sm 153 lexidronam pentasodium-containing compounds (e.g., metastron® or quadramet®) surgery * not specified other * more than 4 weeks since prior pc-spes * more than 4 weeks since prior investigational therapy (medications or devices) * at least 1 week since prior aspirin and/or nonsteroidal anti-inflammatory agents possessing antiplatelet activity * at least 1 week since prior antiplatelet medication, including the following: * abciximab * cilostazol * clopidogrel * dipyridamole * ticlopidine * no concurrent anticoagulant medications (for platelet count \< 50,000/mm\^3), including the following: * dalteparin * danaparoid * enoxaparin * heparin * warfarin * no other concurrent investigational therapy

Keywords: adenocarcinoma of the prostate recurrent prostate cancer stage iv prostate cancer