Clinical trial NCT00490490 (phase 2, status: terminated)
Conditions: lymphoma, non-hodgkin
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: bexxar (tositumomab), potassium iodide (ki)
SMILES: [K+]
Reason stopped: 
    low accrual
  
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