Prostate Cancer
Conditions
Keywords
stage IV prostate cancer, recurrent prostate cancer
Brief 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.
Detailed description
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion 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
Countries
United States