Study to Treat Relapsed Follicular Non-Hodgkin's Lymphoma With Radiation and Bexxar
Condition: Non-Hodgkin's Lymphoma; Follicular Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular; Lymphoma, Non-Hodgkin
Intervention: Iodine I -01 Tositumomab (Bexxar); External Beam Radiation Therapy
Intervention description: Patients will be treated in two dosing phases, each phase includes two infusions. The first phase, termed "dosimetric dose," involves an intravenous administration of 450 mg unlabeled tositumomab followed by an intravenous administration of 5 mCi (0.18 GBq) of I-131 tositumomab for the purpose of determining the rate of whole body clearance of radioactivity (residence time) so that the administered activity (mCi or GBq) to deliver a 75 cGy (or 65 cGy for patients with baseline platelet count from 100,000 to 149,999/mm^3) total body radiation dose can be calculated.; All patients are to receive 20 Gy in 10 fractions of 200 cGy to the PTV
Intervention MeSH terms: Tositumomab I-131
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the feasibility of treating relapsed follicular
      lymphoma with a combination of Bexxar and External Beam Radiotherapy (EBRT). Patients will
      receive EBRT (20 Gy in 10 fractions) followed by Bexxar.
    

Eligibility criteria:

        Inclusion Criteria

          -  Relapsed Stage I-IV (no evidence of bone marrow involvement) Follicular Non- Hodgkin's
             Lymphoma (NHF). Patients must have received at least 1 prior therapeutic regimen of
             chemotherapy or Rituximab and demonstrated progression as demonstrated by biopsy.

          -  One or more of the relapsed sites must be 5 cm or greater in dimension as assessed on
             two dimensional imaging from CT or MRI scan.

          -  Biopsy at time of relapse confirming continued presence of CD 20 positive follicular
             lymphoma.

          -  No anti-cancer therapy for 3 weeks (six weeks if Rituximab, nitrosourea or Mitomycin
             C) prior to study initiation, and fully recovered from all toxicities associated with
             prior surgery, chemotherapy, or immunotherapy.

          -  An IRB-approved signed informed consent.

          -  Expected survival rate greater than 3 months.

          -  Prestudy performance status of 0 or 1 according to the World Health Organization (WHO)
             criteria

          -  Acceptable hematologic status within two weeks prior to patient registration,
             including:

               -  Absolute neutrophil count (ANC) ([segmented neutrophils + bands] x total white
                  blood cells) greater than 1,500/mm^3

               -  Platelet counts greater than 100,000/mm^3

          -  Female patients who are not pregnant or lactating.

          -  Men and women of reproductive potential who are following accepted birth control
             methods (as determined by the treating physician, however, abstinence is not an
             acceptable method).

          -  Patients previously on Phase II drugs if no long-term toxicity is expected, and the
             patient has been off the drug for eight or more weeks with no significant
             post-treatment toxicities observed.

        Exclusion Criteria

          -  Patients with impaired bone marrow reserve, as indicated by one or more of the
             following:

          -  Prior myeloablative therapies with bone marrow transplantation (either autologous or
             allogeneic) or peripheral blood stem cell (PBSC) rescue.

          -  Platelet count > 100,000 cells/mm^3

          -  Hypocellular bone marrow

          -  Marked reduction in bone marrow precursors of one or more cell lines
             (granulocytic,megakaryocytic, erythroid).

          -  History of failed stem cell collection

          -  Presence of bone marrow involvement with follicular lymphoma (FL) > 25% based on bone
             marrow biopsy done within 2 months of enrollment.

          -  Evidence of transformation from original FL to a more aggressive NHL histology.

          -  Prior radioimmunotherapy.

          -  All relapsed sites are < 5 cm in dimension as assessed on two dimensional imaging from
             CT or MRI scan.

          -  Presence of CNS (central nervous system) involvement.

          -  Presence of primary Non-Hodgkin Lymphoma (NHL) of bone.

          -  Patients with HIV or AIDS-related lymphoma.

          -  Patients with abnormal renal function: serum creatinine > 2.0 mg/dL.

          -  Patients who have received prior external beam radiation therapy within three months
             of registration.

          -  Patients who have received G-CSF (granulocyte colony-stimulating factor) or GM-CSF
             (granulocyte-macrophage colony stimulating factor) therapy within two weeks prior to
             treatment.

          -  Serious nonmalignant disease or infection which, in the opinion of the investigator
             and/or the sponsor, would compromise other protocol objectives.

          -  Major surgery, other than diagnostic surgery, within four weeks.

          -  Presence of anti-murine antibody (HAMA) reactivity.