Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma
This trial is active, not recruiting.
|Sponsor||Jonsson Comprehensive Cancer Center|
|Collaborator||National Cancer Institute (NCI)|
|Start date||May 2002|
|Trial identifier||NCT00042913, AMGEN-AMG-412-159, CDR0000069484, NCI-G02-2094, UCLA-0201056|
RATIONALE: Monoclonal antibodies such as epratuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Randomized phase II trial to study the effectiveness of epratuzumab in treating patients who have non-Hodgkin's lymphoma.
Male or female participants at least 18 years old.
DISEASE CHARACTERISTICS: - Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma (NHL) - Relapsed or refractory after at least 1 regimen of standard therapy - Prior therapy may include high-dose chemotherapy with autologous stem cell transplantation (ASCT) or immunotherapy - Bidimensionally measurable disease - At least 1 lesion at least 1.5 cm by CT scan - No primary or secondary CNS lymphoma - No HIV-related lymphoma - No known or suspected transformed lymphoma (prior or concurrent) - No bulky disease (i.e., any single mass greater than 10.0 cm) - No pleural effusion with positive cytology for lymphoma - Most recent pathology specimen available for collection - No rapid disease progression or symptoms that indicate disease progression requiring rapid intervention within the past 2 weeks (e.g., severe shortness of breath, severe pain, or gastrointestinal or genitourinary obstruction) PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 4 months Hematopoietic - Absolute neutrophil count at least 1,000/mm3 - Platelet count at least 50,000/mm3 (transfusion independent) - Hemoglobin at least 9.0 g/dL Hepatic - Bilirubin no greater than 2 times upper limit of normal (ULN) - AST and ALT less than 5 times ULN - Hepatitis B surface antigen negative - Hepatitis C negative Renal - Creatinine no greater than 2 times ULN Other - HIV negative - No other primary malignancy within the past 3 years except squamous cell or basal cell skin cancer, carcinoma in situ of the cervix, or stage I prostate cancer - No other serious nonmalignant condition that would preclude study - No serious infection - No known human antichimeric antibodies or human antihuman antibody positivity - No type 1 hypersensitivity or anaphylactic reactions to murine proteins - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 6 months after study PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - At least 4 weeks since prior immunotherapy (unless clearly progressing) - At least 12 weeks since prior ASCT Chemotherapy - See Disease Characteristics - At least 4 weeks since prior chemotherapy (unless clearly progressing) Endocrine therapy - Not specified Radiotherapy - No prior radioimmunotherapy Surgery - At least 4 weeks since prior major surgery (unless patient has fully recovered) Other - At least 30 days since prior enrollment in clinical trials involving investigational devices or drugs - No concurrent enrollment in other clinical trials involving investigational devices or drugs - No concurrent investigational agents for disease other than NHL
|Official title||A Phase 2 Open Label, Randomized, Dose And Schedule Finding, Clinical Trial Of Immunotherapy With AMG 412 In Subjects With Diffuse Large B-Cell Non-Hodgkin's Lymphoma|
|Principal investigator||Christos E. Emmanouilides, MD|
|Description||OBJECTIVES: - Determine the response rate of patients with diffuse large B-cell non-Hodgkin's lymphoma treated with epratuzumab. - Determine the toxicity of this drug in these patients. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms. - Arm I: Patients receive low-dose epratuzumab IV over 1 hour once weekly for 4 weeks. - Arm II: Patients receive low-dose epratuzumab IV over 1 hour once weekly for 8 weeks. - Arm III: Patients receive high-dose epratuzumab IV over 1 hour once weekly for 4 weeks. Patients are followed every 3 months for 2 years and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 150 patients (50 per treatment arm) will be accrued for this study.|
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