Expired Study
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Omaha, Nebraska 68198


Purpose:

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and deliver cancer-killing substances to them without harming normal cells. Radiolabeled monoclonal antibodies can locate and deliver radioactive cancer-killing substances. PURPOSE: Phase I/II trial to study the effectiveness of combining radiolabeled monoclonal antibodies with rituximab in treating patients who have non-Hodgkin's lymphoma that has not responded to high-dose chemotherapy and autologous stem cell transplantation.


Study summary:

OBJECTIVES: - Determine the maximum tolerated dose of yttrium Y 90-labeled ibritumomab tiuxetan when administered with rituximab in patients with B-cell non-Hodgkin's lymphoma who have relapsed after high-dose chemotherapy and autologous hematopoietic stem cell transplantation. - Determine the safety and efficacy of this regimen in these patients. OUTLINE: This is a dose-escalation study of yttrium Y 90-labeled ibritumomab tiuxetan (IDEC-Y2B8). - Phase I: Patients receive rituximab IV over 4-6 hours followed by indium In 111-labeled ibritumomab tiuxetan (IDEC-In2B8) IV over 10 minutes on day 0. Patients receive rituximab IV again on day 7 followed by IDEC-Y2B8 IV over 10 minutes. Cohorts of 3-6 patients receive escalating doses of IDEC-Y2B8 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 3 of 6 patients experience dose-limiting toxicity. - Phase II: Once the MTD is determined, 58 additional patients are treated at that dose level as in phase I. Patients are followed at 6 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 78 patients (20 for phase I and 58 for phase II) will be accrued for this study within 2 years.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of relapsed B-cell non-Hodgkin's lymphoma (NHL) after high-dose chemotherapy and autologous stem cell transplantation - Less than 25% bone marrow involvement with NHL as evidenced by unilateral or bilateral biopsy within the past 6 weeks - Bone marrow biopsy should demonstrate 15-20% of cellular space occupied by normal hematopoiesis - CD20 antigen expression in tumor tissue within the past year as evidenced by 1 of the following: - Immunoperoxidase stains of tissue showing positive reactivity with L26 antibody - Flow cytometry studies - Measurable disease - More than 2 cm bidimensionally - No active CNS lymphoma - No HIV- or AIDS-related lymphoma PATIENT CHARACTERISTICS: Age: - 19 and over Performance status: - WHO 0-2 Life expectancy: - At least 3 months Hematopoietic: - Absolute neutrophil count greater than 1,500/mm^3 - Platelet count greater than 150,000/mm^3 - No transfusion dependency Hepatic: - Bilirubin less than 2.0 mg/dL - SGOT or SGPT no greater than 2.5 times upper limit of normal (unless due to lymphomatous infiltration of the liver) Renal: - Creatinine less than 2.0 mg/dL - No active obstructive hydronephrosis Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 6 months after study therapy - HIV negative - No active infection requiring oral or IV antibiotics - No human antimurine antibody positivity - No other major medical problems PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - At least 4 weeks since prior growth factors - At least 4 weeks since prior biologic therapy - No dependency on hematopoietic growth factors (e.g., epoetin alfa, interleukin-11, filgrastim [G-CSF], or sargramostim [GM-CSF]) - No prior radioimmunotherapy - No other concurrent biologic therapy of any kind Chemotherapy: - See Disease Characteristics - At least 4 weeks since any prior cytotoxic chemotherapy (6 weeks for nitrosoureas) - No prior fludarabine - No concurrent chemotherapy Endocrine therapy: - No concurrent steroids except as maintenance for non-cancerous disease Radiotherapy: - See Biologic therapy - At least 4 weeks since prior radiotherapy - No prior pelvic radiotherapy - No prior radiotherapy to more than 25% of estimated bone marrow reserve - No concurrent external beam radiotherapy Surgery: - Not specified Other: - Recovered from all prior therapy - At least 4 weeks since prior immunosuppressants - No other concurrent investigational drugs - No other concurrent anti-cancer therapy


NCT ID:

NCT00031642


Primary Contact:

Study Chair
Julie M. Vose, MD
University of Nebraska


Backup Contact:

N/A


Location Contact:

Omaha, Nebraska 68198
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 16, 2017

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