Phase 2 Study of Bexxar in Relapsed/Refractory DLCL
Condition: Lymphoma
MeSH terms: Lymphoma
Intervention: Bexxar; Acetaminophen; Diphenhydramine; Potassium Iodide (KI)
Intervention description: Bexxar is a radioimmunotherapeutic drug, an antibody that specifically attaches to the CD20 antigen, which is present on the surfaces of B cells and B cell lymphoma cells. The radioactive isotope then gives off radiation, which kills the cells.
Bexxar will be administered to provide the following patient-specific radiotherapy:
Platelet count of 150,000/mm³ = 75 cGy
Platelet count ≥ 100,000/mm³ but < 150,000/mm³ = 65 cGy; As premedication 30 to 60 minutes before antibody infusion; 650 mg, oral. Used to as to relieve pain; As premedication 30 to 60 minutes before antibody infusion; 50 mg, oral. Used to prevent inflammation or allergic reactions; Administered to prevent thyroid blockage 130 mg orally 3 times a day,
Intervention MeSH terms: Acetaminophen; Iodine; Diphenhydramine; Promethazine; Cadexomer iodine; Tositumomab I-131; Lugol's solution; Pharmaceutical Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to obtain safety and efficacy data using Bexxar in patients with
      relapsed/refractory diffuse large cell Non-Hodgkin's lymphoma (DLCL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically-confirmed, diffuse large cell lymphoma (DLCL), CD20+ B-cell non-Hodgkin
             lymphoma (NHL) who have relapsed after chemotherapy or are chemotherapy resistant,
             without prior history of low grade NHL. The patient must have failed at least one
             chemotherapy regimen containing an anthracycline or equivalent chemotherapeutic agent.

          -  No anticancer treatment for three weeks prior to the treatment dose of Bexxar (6 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

          -  Prestudy Karnofsky Performance Status of ≥ 70%

          -  Absolute neutrophil count (ANC) ≥ 1,500/mm³

          -  Platelet count ≥ 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

          -  Female patients who are not pregnant

          -  Not lactating

        Exclusion Criteria:

          -  Prior myeloablative therapies with bone marrow transplantation or peripheral stem cell
             rescue

          -  Platelet count < 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

          -  Patients with known HIV or AIDS-related lymphoma

          -  Patients with evidence of myelodysplasia on bone marrow biopsy

          -  Patients who have received prior external beam radiation therapy to more than 25% of
             active bone marrow

          -  Patients who have received filgrastim or sargramostim therapy within 3 weeks prior to
             treatment

          -  Pregnant

          -  Lactating

          -  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,
             would compromise other protocol objectives

          -  Another primary malignancy (other than squamous cell and basal cell carcinoma of the
             skin, in situ carcinoma of the cervix, or treated prostate cancer with stable prostate
             specific antigen levels) for which the patients has not been disease-free for at least
             3 years

          -  Major surgery, other than diagnostic surgery, within 4 weeks

          -  Patients with pleural effusion