Iodine I 131 Monoclonal Antibody BC8 Before Autologous Stem Cell Transplant in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma
Condition: Recurrent B-Cell Non-Hodgkin Lymphoma; Recurrent Hodgkin Lymphoma; Recurrent T-Cell Non-Hodgkin Lymphoma; Refractory B-Cell Non-Hodgkin Lymphoma; Refractory Hodgkin Lymphoma; Refractory T-Cell Non-Hodgkin Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Hodgkin Disease; Lymphoma, B-Cell; Lymphoma, T-Cell; Recurrence
Intervention: Autologous Hematopoietic Stem Cell Transplantation; Iodine I 131 Monoclonal Antibody BC8; Laboratory Biomarker Analysis
Intervention description: Autologous stem cells given via central catheter; Given IV; Correlative studies
Intervention MeSH terms: Iodine; Cadexomer iodine; Antineoplastic Agents, Immunological; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: A single site, open label clinical trial.
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase I trial studies the side effects and best dose of iodine I 131 monoclonal antibody
      BC8 when given before autologous stem cell transplant in treating patients with Hodgkin
      lymphoma or non-Hodgkin lymphoma that has returned after a period of improvement or does not
      respond to treatment. Radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal
      antibody BC8, can find cancer cells and carry cancer-killing substances to them without
      harming normal cells. Giving iodine I 131 monoclonal antibody BC8 before an autologous stem
      cell transplant may kill more cancer cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have a histologically confirmed diagnosis of B-NHL, T-NHL, or HL; CD45
             antigen expression must be documented on tumor specimens in all cases except HL, in
             whom histologic demonstration of CD45+ cells adjacent to the Reed Sternberg cells is
             required

          -  Patients must have received at least one prior standard systemic therapy with
             documented recurrent or refractory disease

          -  Mantle cell lymphoma (MCL), T-NHL, or other high-risk malignancies may be
             enrolled/transplanted in complete remission (CR)/first partial remission (PR1)

          -  Patients are preferred to have either a tumor mass amenable to core needle biopsy
             during the dosimetry phase, or a measurable tumor mass with at least one site of
             involvement measuring 2.0 cm in largest dimension on computed tomography (CT) imaging
             for purposes of planar and/or single-photon emission CT (SPECT)/CT tumor dosimetry
             (patients with disease that does not allow tumor dosimetry will be allowed on study
             since they still can contribute toward achieving the primary endpoint, but these
             patients will be given a lower priority over those with evaluable disease)

          -  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 a minimum of >= 4 x10^6 CD34/kg
             autologous hematopoietic stem cells harvested and cryopreserved and divided into 2
             aliquots of at least >= 2 x10^6 CD34/kg each; patients with a history of prior
             autologous hematopoietic cell transplant (HCT) are only required to have >= 2x10^6
             CD34/kg stored

          -  Patients must have an expected survival of > 60 days and must be free of major
             infection

        Exclusion Criteria:

          -  Circulating human anti-mouse antibody (HAMA), to be determined before each infusion

          -  Systemic anti-lymphoma therapy given in the previous 30 days before the scheduled
             therapy dose with the exception of rituximab

          -  Inability to understand or give an informed consent

          -  Lymphoma involving the central nervous system

          -  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, forced
             expiratory volume in one second (FEV1) < 70% predicted, acquired immune deficiency
             syndrome [AIDS], etc.)

          -  Known human immunodeficiency virus (HIV) seropositivity

          -  Pregnancy or breast feeding

          -  Prior allogeneic bone marrow or stem cell transplant

          -  Prior autologous bone marrow or stem cell transplant or prior radiation therapy (RT) >
             20 Gy to a critical organ within 1 year of enrollment

          -  Presence of circulating lymphoma cells by morphology or flow cytometry (> 0.1%) at or
             near the time of peripheral blood stem cell (PBSC) collection if unpurged/unselected
             PBSC are to be used (patients with cryopreserved stem cells which are negative [=<
             0.1% involved] by flow cytometry will also be considered eligible)

          -  Southwest Oncology Group (SWOG) performance status >= 2.0

          -  Unable to perform self-care during radiation isolation

          -  Expected survival if untreated less than 60 days