Radiolabeled Monoclonal Antibody in Treating Patients With Progressive Metastatic Androgen-Independent Adenocarcinoma (Cancer) of the Prostate

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase II Trial Of Lu Radiolabeled Monoclonal Antibody HuJ591-GS (Lu-J591) In Patients With Metastatic Androgen-Independent Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: lutetium Lu 177 monoclonal antibody J591


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: lutetium Lu 177 monoclonal antibody J591|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical response as measured by prostate-specific antigen level at 8 weeks after treatment |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent prostate cancer, adenocarcinoma of the prostate, stage IV prostate cancer