A Phase II Trial Evaluating: Radioiodinated Anti-B1 (Anti-CD20) Antibody With Autologous Stem Cell Transplantation For Relapsed Or Refractory Non-Hodgkin's Lymphoma In Patients 60 Years Of Age And Older
Data Collection
Immune System Diseases+5
+ Immunoproliferative Disorders
+ Lymphatic Diseases
Treatment Study
Summary
Study start date: October 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.25 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 60 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location