Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pilot Trial of Humanized Monoclonal Antibody J591 in Patients With Progressive Androgen-Independent Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Biological: monoclonal antibody huJ591


Participation Criteria
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Eligibility Criteria
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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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: monoclonal antibody huJ591|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

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