Study of Bexxar <Tositumomab> Combined With External Beam Radiation Therapy
Condition: Lymphoma, Non-Hodgkin
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: Bexxar (tositumomab); External beam radiotherapy (XRT); Potassium Iodide (KI)
Intervention description: Tositumomab is a CD20-directed radiotherapeutic (131-iodine) monoclonal antibody indicated for the treatment of patients with CD20-positive, relapsed or refractory, low-grade, follicular, or transformed non-Hodgkin's lymphoma who have progressed during or after rituximab therapy, including patients with rituximab-refractory non-Hodgkin's lymphoma. Tositumomab (standard regimen) will be administered at whole body exposure of 75 cGy.; Patient-specific XRT will begin within 24 hours of administration of the therapeutic dose of tositumomab. Subjects will receive local XRT to bulky sites of disease measuring at least 5 cm in at least one dimension. The size and number of fields to be treated will determined by the investigators, but will encompass the patient's most symptomatic/threatening site(s) of disease and not cumulatively include more than 25% of the active bone marrow. Subjects will be treated with the 2 x 2 Gy regimen (2 daily fractions of 2 Gy). Sites of disease previously-irradiated with 30 to 40 Gy will not be treated on this study.; Potassium iodide (KI) will be administered as:
Saturated solution potassium iodide (SSKI) 4 drops orally 3-times-a-day,
Lugol's solution 20 drops orally 3-times-a-day, OR
KI tablets 130 mg orally once per day KI treatment will start at least 24 hours prior to tositumomab, and continue daily for 14 days following the last dose of tositumomab
Intervention MeSH terms: Iodine; Lugol's solution; Pharmaceutical Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to assess the response rate of patients with relapsed or
      refractory low-grade or transformed low-grade, CD20-positive, B-cell non-Hodgkin's lymphoma
      to Iodine-131 (I-131) tositumomab (Bexxar) therapy plus local palliative radiation therapy
      (XRT).
    

Eligibility criteria:

        INCLUSION CRITERIA

          -  Histologically confirmed low grade CD20+ B cell non-Hodgkin lymphoma (NHL) patients
             who have relapsed after chemotherapy or are chemotherapy resistant and have one or
             more sites of disease measuring more than 5 cm.

          -  The patients must have failed at least one chemotherapy regimen

          -  No anticancer treatment for three weeks prior to study initiation (six weeks if
             Rituximab, nitrosourea or Mitomycin C)

          -  Fully recovered from all toxicities associated with prior surgery, radiation,
             chemotherapy or immunotherapy

          -  An institutional review board- (IRB)-approved signed informed consent

          -  Age 19 years or older

          -  Expected survival of at least 6 months

          -  Prestudy Performance Status of 0, 1 or 2 according to the World Health Organization
             (WHO)

          -  Absolute neutrophil count (ANC) of at least 1,500/mm³

          -  Platelet count at least 100,000/mm³

          -  Hct > 30%

          -  Hgb > 9.0 gm

          -  Bilirubin ≤ 2.0

          -  Creatinine ≤ 2.0

          -  Bone marrow involvement with lymphoma less than 25% (bilateral bone marrow) within 6
             weeks of enrollment

          -  Acceptable birth control method for men and women

        EXCLUSION CRITERIA

          -  Disease progression within 3 months of last chemotherapy

          -  Prior myeloablative therapies with bone marrow transplantation or peripheral stem cell
             rescue

          -  Platelet count less than 100,000/mm³

          -  Hypocellular bone marrow (≤ 15% cellularity)

          -  Marked reduction in bone marrow precursors of one or more cell lines

          -  History of failed stem cell collection

          -  Prior treatment with fludarabine

          -  Prior radioimmunotherapy

          -  Presence of central nervous system (CNS) lymphoma

          -  HIV or AIDS-related lymphoma

          -  Evidence of myelodysplasia on bone marrow biopsy

          -  Abnormal bone marrow cytogenetics

          -  Patients who have received prior external beam radiation therapy to more than 25% of
             active bone marrow

          -  Patients who have received filgrastim

          -  Sargramostim therapy within 3 weeks prior to treatment

          -  Presence of human anti-mouse antibody (HAMA) reactivity in patients with prior
             exposure to murine antibodies or proteins

          -  Serious nonmalignant disease or infection, which, in the opinion of the investigator
             and/or sponsor, would compromise other protocol objectives

          -  Another primary malignancy (other than squamous cell and basal cell cancer of the
             skin, in situ carcinoma of the cervix, or treated prostate cancer with stable
             prostate-specific antigen, PSA) for which the patients has not been disease free for
             at least 3 years

          -  Major surgery, other than diagnostic surgery within 4 weeks

          -  Pleural effusion

          -  Pregnant

          -  Lactating