Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00024232


Primary Contact:

Study Chair
Michael Morris, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 11, 2017

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