Expired Study
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Seattle, Washington 98109


Purpose:

RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab, can locate cancer cells and deliver radioactive cancer-killing substances to them without harming normal cells. Combining a radiolabeled monoclonal antibody with autologous stem cell transplantation may be an effective treatment for non-Hodgkin's lymphoma. PURPOSE: Phase II trial to study the effectiveness of combining iodine I 131 tositumomab with autologous stem cell transplantation in treating older patients who have relapsed or refractory non-Hodgkin's lymphoma.


Study summary:

OBJECTIVES: Primary - Determine the progression-free survival of older patients with relapsed or refractory non-Hodgkin's lymphoma treated with iodine I 131 tositumomab followed by autologous stem cell transplantation. Secondary - Determine the overall survival of patients treated with this regimen. - Determine the toxicity and tolerability of this regimen in these patients. OUTLINE: - Radioimmunotherapy: Patients receive a test dose of iodine I 131 tositumomab on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over 1 hour on day -14 and are entered into radiation isolation until day -4. - Autologous stem cell transplantation: Patients undergo autologous bone marrow or peripheral blood stem cell transplantation on day 0. Patients undergoing bone marrow transplantation receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously beginning on day 0 and continuing until blood counts recover. Patients are followed at 1, 3, 6, and 12 months and then annually thereafter. PROJECTED ACCRUAL: A total of 24-30 patients will be accrued for this study within 2 years.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed non-Hodgkin's lymphoma - CD20+ disease - Failed at least 1 prior standard systemic therapy - Persistent lymphoma by physical examination, radiographic studies, bone marrow evaluations, flow cytometry, or polymerase chain reaction - Tumor burden less than 500 cc by computed tomography or MRI - No splenomegaly - Autologous hematopoietic stem cells or bone marrow harvested and cryopreserved - No circulating lymphoma cells by morphology or flow cytometry at or near the time of peripheral blood stem cell (PBSC) collection if unpurged PBSCs are to be used - 10% or less marrow involvement by flow cytometry or morphology if purged bone marrow is to be used - No CNS lymphoma - No chronic lymphocytic leukemia or small lymphocytic lymphoma/well-differentiated lymphocytic lymphoma PATIENT CHARACTERISTICS: Age - 60 to 80 Performance status - SWOG 0-1 Life expectancy - More than 60 days Hematopoietic - See Disease Characteristics Hepatic - Bilirubin less than 1.5 mg/dL Renal - Creatinine less than 2.0 mg/dL Cardiovascular - No active coronary artery disease Pulmonary - FEV_1 at least 70% of expected - Vital capacity at least 70% of expected Other - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - Able to perform self-care during radiation isolation - No major organ dysfunction - No major infection - No circulating anti-mouse antibody - No other serious medical condition considered to represent contraindications to bone marrow transplantation - No competing causes of death that would predict life span to be less than 10 additional years PRIOR CONCURRENT THERAPY: Biologic therapy - No prior bone marrow or stem cell transplantation Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy greater than 20 Gy to any critical normal organ (e.g., lung, liver, spinal cord, or more than 25% of red marrow) Surgery - Not specified Other - More than 30 days since prior systemic antilymphoma therapy


NCT ID:

NCT00073931


Primary Contact:

Study Chair
Ajay K. Gopal, MD
Fred Hutchinson Cancer Research Center


Backup Contact:

N/A


Location Contact:

Seattle, Washington 98109
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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