Iodine-131 Anti-B1 Antibody Consolidation for Patients With Non-Hodgkin's Lymphoma Following First-line CHOP
Condition: Lymphoma, Non-Hodgkin
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: tositumomab and iodine I-131 tositumomab
Intervention description: Subjects received the following treatments of TST/I-131 TST by intravenous (IV) infusion:
Dosimetric Dose: 450 mg of TST infused over 1 hour immediately followed by 35 mg of TST labeled with 5 milliCuries (mCi) of I 131 infused over 30 minutes.
Therapeutic Dose: 7 to 14 days after the dosimetric dose, 450 mg of TST infused over 60 minutes, immediately followed by 35 mg of TST labeled with the subject-specific mCi activity of I 131 needed to deliver a total body dose of 75 centiGrays (cGy), infused over 30 minutes for subjects with a platelet count of 150,000/mm3. Subjects with platelet counts of 100,000 to 149,999/mm3 received 65 cGy, and obese subjects were dosed based upon 137% of their calculated lean body mass.
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: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: radioimmunotherapy; Iodine 131 Tositumomab

Summary:

      This is a multicenter study for the long-term follow-up of surviving patients who are
      expected to complete or who have completed at least two years of follow-up after treatment
      with Iodine I 131 Tositumomab (BEXXAR) on studies CP-97-011, CP-98-025, CP-99-032, or
      CP-99-036. All patients will be assessed for survival and disease status, including
      subsequent therapy for Diffuse Large B-cell Non-Hodgkin's Lymphoma (NHL), and for long-term
      safety. Additionally laboratory evaluations consisting of a thyroid stimulating hormone (TSH)
      level and a complete blood cell (CBC) count with a differential and platelet count will be
      obtained annually. Additionally, patients who remain in long-term response following Iodine I
      131 Tositumomab treatment will be followed for response and progression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female subjects age 18 to 80 years, inclusive, with any International
             Prognostic Index score; treated with 6 or more cycles of first-line CHOP chemotherapy
             and achieved a PR, CRu, or CR

          -  de novo diffuse large B-cell NHL according to the REAL classification; Ann Arbor stage
             III, stage IV, or bulky stage II disease (any mass ≥10 cm in diameter)

          -  less than an average of 25% of the intratrabecular marrow space involved by NHL in
             bilateral bone marrow biopsy specimens or <10% involvement with NHL from unilateral
             bone marrow biopsy; tumor tissue expressing the CD20 antigen

          -  ≥60% performance status on the Karnofsky Performance Scale and an anticipated survival
             of at least 3 months

          -  absolute neutrophil count (ANC) ≥1500 cells/mm3 and platelet count ≥100,000/mm3

          -  adequate renal function (serum creatinine <1.5 × upper limit of normal [ULN]) and
             hepatic function (total bilirubin ≤2.0 × ULN and aspartate aminotransferase <5 × ULN)

        Exclusion Criteria:

          -  prior radiation, prior biological therapy, or prior chemotherapy other than first-line
             CHOP

          -  active bilateral obstructive hydronephrosis

          -  New York Heart Association class III or IV heart disease or other serious illness

          -  prior malignancy other than lymphoma (except for adequately treated skin cancer, in
             situ cervical cancer, or other cancer for which they had been disease-free for >5
             years)

          -  human immunodeficiency virus infection

          -  HAMA positive

          -  brain or leptomeningeal metastases at any time since diagnosis

          -  active infection requiring intravenous anti-infectives

          -  pregnant or breastfeeding