Iodine I 131 Tositumomab or Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Observational

Summary: 
      RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab and yttrium Y
      90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them
      without harming normal cells. This may be an effective treatment for non-Hodgkin's lymphoma.

      PURPOSE: This clinical trial is studying the side effects, best dose, and how well iodine I
      131 tositumomab or yttrium Y 90 ibritumomab tiuxetan works in treating patients with
      non-Hodgkin's lymphoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the relationship between estimated absorbed dose and tumor response using
           different dosimetric methodologies in patients with non-Hodgkin's lymphoma treated with
           iodine I 131 tositumomab or yttrium Y 90 ibritumomab tiuxetan.

        -  Determine the relationship between estimated absorbed dose and normal organ toxicity
           using different dosimetric methodologies in these patients.

      Secondary

        -  Assess the difference in the dose-response relationship between dosimetric methodologies
           in these patients.

        -  Assess the influence of prior therapy on the dose-response relationship for hematologic
           toxicity in these patients.

      OUTLINE: Patients are stratified according to planned radioimmunotherapy treatment (iodine I
      131 tositumomab vs yttrium Y 90 ibritumomab tiuxetan).

        -  Stratum 1: Patients receive dosimetric rituximab IV followed by indium In 111 (^111In)
           ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo positron emission
           tomography (PET)/CT scans and single-photon emission computed tomography (SPECT)/CT
           scans between 2-24, 48-72, and 90-120 hours after ^111In ibritumomab tiuxetan
           administration. Patients who have acceptable biodistribution receive therapeutic
           rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes between
           days 7-9.

        -  Stratum 2: Patients receive dosimetric tositumomab IV over 60 minutes followed by iodine
           I 131 (^131I) tositumomab IV over 20 minutes on day 0. Patients undergo PET/CT scans and
           SPECT/CT scans on days 0; 2, 3 or 4; and 6 or 7. Patients who have acceptable
           biodistribution receive therapeutic tositumomab IV over 60 minutes followed by ^131I
           tositumomab IV over 20 minutes on approximately day 7.

      In both strata, blood is collected at baseline to measure FLT-3 levels. All patients also
      undergo a baseline PET/CT scan.

      After completion of study treatment, patients are followed every 3 months for 1 year and then
      every 6 months thereafter.

      PROJECTED ACCRUAL: A total of 88 patients will be accrued for this study.
    

Intervention name(s): Patient-specific dosimetry; conventional dosimetry
Intervention type(s): Device; Device
Intervention description(s): Tumor absorbed dose calculation using patient-specific 3D-RD dosimetry software.
Patients receive dosimetric tositumomab IV over 60 minutes followed by iodine I 131 (^131I) tositumomab IV over 20 minutes on day 0. Patients undergo PET/CT scans and SPECT/CT scans on days 0; 2, 3 or 4; and 6 or 7. Patients who have acceptable biodistribution receive therapeutic tositumomab IV over 60 minutes followed by ^131I tositumomab IV over 20 minutes on approximately day 7.; Doses calculated using conventional dosimetry software.
Patients receive dosimetric rituximab IV followed by indium In 111 (^111In) ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo positron emission tomography (PET)/CT scans and single-photon emission computed tomography (SPECT)/CT scans between 2-24, 48-72, and 90-120 hours after ^111In ibritumomab tiuxetan administration. Patients who have acceptable biodistribution receive therapeutic rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes between days 7-9.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients treated for NHL by rituximab or zevalin
      
Keywords: extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; recurrent adult Burkitt lymphoma; recurrent adult diffuse large cell lymphoma; recurrent adult diffuse small cleaved cell lymphoma; recurrent adult diffuse mixed cell 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; recurrent marginal zone lymphoma; recurrent small lymphocytic lymphoma; splenic marginal zone lymphoma; stage III adult Burkitt lymphoma; stage III adult diffuse large cell lymphoma; stage III adult diffuse mixed cell lymphoma; stage III adult diffuse small cleaved cell lymphoma; stage III adult immunoblastic large cell lymphoma; stage III adult lymphoblastic lymphoma; stage III grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage III grade 3 follicular lymphoma; stage III mantle cell lymphoma; stage III marginal zone lymphoma; stage III small lymphocytic lymphoma; stage IV adult Burkitt lymphoma; stage IV adult diffuse large cell lymphoma; stage IV adult diffuse small cleaved cell lymphoma; stage IV adult diffuse mixed cell lymphoma; stage IV adult immunoblastic large cell lymphoma; stage IV adult lymphoblastic lymphoma; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma; stage IV grade 3 follicular lymphoma; stage IV mantle cell lymphoma; stage IV marginal zone lymphoma; stage IV small lymphocytic lymphoma; Waldenström macroglobulinemia; contiguous stage II adult Burkitt lymphoma; contiguous stage II adult diffuse large cell lymphoma; contiguous stage II adult diffuse mixed cell lymphoma; contiguous stage II adult diffuse small cleaved cell lymphoma; contiguous stage II adult immunoblastic large cell lymphoma; contiguous stage II adult lymphoblastic lymphoma; contiguous stage II grade 1 follicular lymphoma; contiguous stage II grade 2 follicular lymphoma; contiguous stage II grade 3 follicular lymphoma; contiguous stage II mantle cell lymphoma; contiguous stage II marginal zone lymphoma; contiguous stage II small lymphocytic lymphoma; noncontiguous stage II adult Burkitt lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II adult diffuse mixed cell lymphoma; noncontiguous stage II adult diffuse small cleaved cell lymphoma; noncontiguous stage II adult immunoblastic large cell lymphoma; noncontiguous stage II adult lymphoblastic lymphoma; noncontiguous stage II grade 1 follicular lymphoma; noncontiguous stage II grade 2 follicular lymphoma; noncontiguous stage II grade 3 follicular lymphoma; noncontiguous stage II mantle cell lymphoma; noncontiguous stage II marginal zone lymphoma; noncontiguous stage II small lymphocytic lymphoma; stage I adult Burkitt lymphoma; stage I adult diffuse large cell lymphoma; stage I adult diffuse mixed cell lymphoma; stage I adult diffuse small cleaved cell lymphoma; stage I adult immunoblastic large cell lymphoma; stage I adult lymphoblastic lymphoma; stage I grade 1 follicular lymphoma; stage I grade 2 follicular lymphoma; stage I grade 3 follicular lymphoma; stage I mantle cell lymphoma; stage I marginal zone lymphoma; stage I small lymphocytic lymphoma; adult grade III lymphomatoid granulomatosis; recurrent adult grade III lymphomatoid granulomatosis; primary central nervous system non-Hodgkin lymphoma; adult nasal type extranodal NK/T-cell lymphoma