Lymphoma
Conditions
Keywords
recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult Burkitt lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALfilgrastim
5 µg/kg/day subcutaneously
BIOLOGICALsargramostim
250µg/m2/d subcutaneously
PROCEDUREautologous bone marrow transplantation
autologous stem cells given via central catheter
PROCEDUREperipheral blood stem cell transplantation
autologous stem cells given via central catheter
given intravenously (test dose of 1.7-10 mg/kg tositumomab antibody radiolabeled with \ 10 mCi I-131) or via central catheter (therapy dose of 1.7-10 mg/kg tositumomab radiolabeled with individually calculated therapy dose of I-131)
Sponsors
National Cancer Institute (NCI)
Fred Hutchinson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival measured continuously | from date of transplant through date of death |
Countries
United States
Outcome results
None listed