Tositumomab and Iodine I 131 Tositumomab in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma in First Remission
Condition: Lymphoid Leukemia in Remission; Stage I Chronic Lymphocytic Leukemia; Stage II Chronic Lymphocytic Leukemia; Stage III Chronic Lymphocytic Leukemia; Stage III Small Lymphocytic Lymphoma; Stage IV Chronic Lymphocytic Leukemia; Stage IV Small Lymphocytic Lymphoma
MeSH terms: Lymphoma; Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Tositumomab and Iodine I 131 Tositumomab
Intervention description: Give IV
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: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This phase II trial studies how well tositumomab and iodine I 131 tositumomab works in
      treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
      that have had their first decrease in or disappearance of signs and symptoms of cancer (first
      remission). Monoclonal antibodies, such as tositumomab and iodine I 131 tositumomab, may
      block cancer growth in different ways by targeting certain cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a diagnosis of cluster of differentiation (CD)20+ CLL/SLL; prior to the
             first treatment patients with CLL must have been either Rai stage III/IV disease or
             Rai stage I/II with evidence of disease activity as defined by the National Cancer
             Institute (NCI) 1996 guidelines, and patients with SLL must have been Stage III or IV
             per Ann Arbor staging system

          -  Patient has received prior therapy and is in 1st remission with a partial or complete
             response to treatment

          -  Patients must have no more than 25% of the intratrabecular marrow space involved by
             leukemia in bone marrow biopsy specimens as assessed microscopically after completion
             of treatment; bilateral posterior iliac crest core biopsies are required if the
             percentage of intratrabecular space involved exceeds 10% on a unilateral biopsy; the
             mean of bilateral biopsies must be no more than 25%

          -  Patient must have consented to participate in the study and signed and dated an
             appropriate institutional review board (IRB)-approved consent form that conforms to
             federal and institutional guidelines

          -  Patient must have a Eastern Cooperative Oncology Group (ECOG) performance status of 0,
             1 or 2 (0 = fully active, able to carry on all pre-disease performance without
             restriction; 1 = restricted in physically strenuous activity but ambulatory and
             ambulatory and able to carry out work of a light or sedentary nature, e.g., light
             house work, office work; 2 = ambulatory and capable of all self-care but unable to
             carry out any work activities and is up and about more than 50% of waking hours)

          -  Patient must have an anticipated survival of at least 3 months

          -  Granulocytes >= 1,500/uL within 14 days of planned dosimetric infusion

          -  Platelets >= 100,000/uL within 14 days of planned dosimetric infusion

          -  White blood count =< 20,000/mm^3

          -  Serum creatinine < 2 times upper limit of normal

          -  Total bilirubin < 2 times upper limit of normal

          -  Aspartate aminotransferase (AST) < 5 times upper limit of normal

          -  Males and females must agree to use a contraceptive method from enrollment to 6 months
             after receiving I-131 labeled tositumomab

        Exclusion Criteria:

          -  Patients who have received prior radiolabeled antibody

          -  Patients with active hemolysis

          -  Patients must not require sustained transfusion support of blood products

          -  Patients in 2nd remission or beyond

          -  Patients who have undergone treatment with either stem cell or bone marrow transplant

          -  Patients with active obstructive hydronephrosis

          -  Patients with evidence of any significant systemic illness, active hepatitis B
             infection or other active infection at the time of study entry

          -  Patients with New York Heart Association class III or IV heart disease or other
             serious illness that would preclude evaluation

          -  Patients with known human immunodeficiency virus (HIV) infection

          -  Patients who are pregnant or nursing

          -  Patients with prior malignancy other than CLL/SLL, except for adequately treated skin
             cancer (basal cell or squamous cell carcinoma), in situ cervical cancer, or other
             cancer for which the patient has been disease-free for 5 years unless approved by the
             principal investigator (PI)

          -  Patients with active brain or leptomeningeal involvement by malignancy

          -  Patients who have, in the opinion of the investigator, other medical, social, or
             psychosocial factors that may negatively impact compliance or their safety by
             participation in this study