Expired Study
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New York, New York 10021


Purpose:

RATIONALE: Monoclonal antibodies, such as hA20, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. PURPOSE: This phase I trial is studying the side effects and best dose of monoclonal antibody hA20 in treating patients with refractory B-cell non-Hodgkin's lymphoma.


Study summary:

OBJECTIVES: Primary - Determine the safety and tolerability of monoclonal antibody hA20 in patients with refractory CD20-positive B-cell non-Hodgkin's lymphoma. - Determine the immunogenicity of this drug in these patients. Secondary - Determine the pharmacodynamics and pharmacokinetics of this drug in these patients. - Determine, preliminarily, the efficacy of this drug in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive monoclonal antibody hA20 IV once weekly for 4 weeks. Cohorts of 3-6 patients receive escalating doses of monoclonal antibody hA20. Up to 10 additional patients are then entered at 1 or more dose levels to determine the optimal dose. After completion of study treatment, patients are followed weekly for 4 weeks, at 8 and 12 weeks, and then every 3 months until disease progression. PROJECTED ACCRUAL: Approximately 19-28 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed B-cell non-Hodgkin's lymphoma (NHL) - Any grade allowed - CD20-positive disease - Measurable disease, defined as ≥ 1 bidimensionally measurable lesion > 1.5 cm by CT scan - Failed ≥ 1 prior standard chemotherapy regimen OR rituximab therapy for NHL PATIENT CHARACTERISTICS: Age - Over 18 Performance status - ECOG 0-1 OR - Karnofsky 80-100% Life expectancy - At least 6 months Hematopoietic - Hemoglobin > 10 g/dL* - Absolute neutrophil count > 1,500/mm^3* - Platelet count > 100,000/mm^3* NOTE: *Transfusion independent Hepatic - Bilirubin < 1.5 times upper limit of normal (ULN) - AST and ALT < 2.5 times ULN Renal - Creatinine < 1.5 times ULN Other - Not pregnant or nursing - Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - At least 12 months since prior rituximab Chemotherapy - See Disease Characteristics - At least 4 weeks since prior investigational or conventional chemotherapy and recovered Endocrine therapy - Not specified Radiotherapy - Recovered from prior investigational or conventional radiotherapy - At least 4 weeks since prior radiotherapy to the index lesion Surgery - Recovered from prior investigational or conventional surgery


NCT ID:

NCT00112970


Primary Contact:

Study Chair
William A. Wegener, MD, PhD
Immunomedics, Inc.


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States

John P. Leonard, MD
Phone: 973-605-8200 ext. 182
Email: jpleonar@med.cornell.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: December 17, 2017

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