Anti-CD20 Radioimmunotherapy Before Chemotherapy and Stem Cell Transplant in Treating Patients With High-Risk B-Cell Malignancies
Condition: Burkitt Lymphoma; CD20-Positive Neoplastic Cells Present; Diffuse Large B-Cell Lymphoma; Indolent Non-Hodgkin Lymphoma; Mantle Cell Lymphoma; Recurrent B-Cell Non-Hodgkin Lymphoma; Refractory Mature B-Cell Non-Hodgkin Lymphoma
MeSH terms: Burkitt Lymphoma; Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma, Mantle-Cell; Lymphoma, Large B-Cell, Diffuse
Intervention: Anti-CD20 B9E9 scFv-Streptavidin Fusion Protein; Autologous Hematopoietic Stem Cell Transplantation; Carmustine; Clearing Agent; Cytarabine; Etoposide; Indium In 111-DOTA-Biotin; Laboratory Biomarker Analysis; Melphalan; Peripheral Blood Stem Cell Transplantation; Pharmacological Study; Yttrium Y 90-DOTA-Biotin
Intervention description: Given IV; Undergo autologous PBSCT; Given IV; Given IV; Given IV; Given IV; Given IV; Correlative studies; Given IV; Undergo autologous PBSCT; Correlative studies; Given IV
Intervention MeSH terms: Biotin; Cytarabine; Etoposide; Podophyllotoxin; Etoposide phosphate; Melphalan; Mechlorethamine; Carmustine; Nitrogen Mustard Compounds; 1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase I/II trial studies the side effects and best dose of anti-cluster of
      differentiation (CD)20 radioimmunotherapy (RIT), and to see how well it works when given
      before chemotherapy and stem cell transplant in treating patients with B-cell malignancies
      that have not responded to treatment or have come back after responding to treatment. CD20 is
      a protein found on the cells of a type of cancer cell called B-cells. Anti-CD20 RIT attaches
      radioactive material to a drug that is designed to target CD20, which brings radioactive
      material to the cancer cells to kill the cells. This may kill more tumor cells while causing
      fewer side effects to healthy tissue. Adding anti-CD20 to standard chemotherapy and stem cell
      transplant may be more effective in treating patients with B-cell malignancies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have a histologically confirmed diagnosis of lymphoma expressing the
             CD20 antigen and generally must have failed at least one prior standard systemic
             therapy; the exception will be mantle cell lymphoma (MCL) patients, who may be
             enrolled while in first complete remission (CR) as well as other select high-risk
             lymphomas (e.g., Burkitt?s, double hit diffuse large B-cell lymphoma [DLBCL],
             transformed indolent B-cell non-Hodgkin lymphoma [B-NHL], etc.) in accordance with
             current transplant standard of care for these patients

          -  Creatinine (Cr) < 2.0

          -  Bilirubin < 1.5 mg/dL, with the exception of patients thought to have Gilbert?s
             syndrome, who may have a total bilirubin above 1.5 mg/dL

          -  All patients eligible for therapeutic study must have (>= 2 x 10^6 CD34/kg) autologous
             hematopoietic stem cells harvested and cryopreserved

          -  Patients must have an expected survival of > 60 days and must be free of major
             infection

          -  Patients of childbearing potential must agree to abstinence or the use of effective
             contraception

          -  DONOR SELECTION: Not applicable; this protocol employs autologous transplantation,
             utilizing the patient?s own hematopoietic stem cells obtained from either the
             peripheral blood or bone marrow

        Exclusion Criteria:

          -  Systemic anti-lymphoma therapy given in the previous 30 days before the scheduled 90Y
             therapy dose

          -  Inability to understand or give an informed consent

          -  Prior radiation > 20 Gy to any critical normal organ (e.g., lung, liver, spinal cord,
             both kidneys) within 1 year of the treatment date

          -  Active central nervous system lymphoma

          -  Other serious medical conditions considered to represent contraindications to bone
             marrow transplant (BMT) (e.g., abnormally decreased cardiac ejection fraction,
             diffusion capacity of the lung for carbon monoxide [DLCO] < 50% predicted, patient on
             supplemental oxygen, acquired immune deficiency syndrome [AIDS], etc.)

          -  Pregnancy or breast feeding

          -  Prior bone marrow or stem cell transplant

          -  Southwest Oncology Group (SWOG) performance status >= 2.0

          -  Known sensitivity to kanamycin and other aminoglycosides; patients with known
             hypersensitivity to kanamycin or any other aminoglycoside antibiotic will be excluded