Expanded Access Study Of BEXXAR® For Low Grade And Transformed Low-Grade Non-Hodgkin's Lymphoma
Condition: Lymphoma, Non-Hodgkin
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: Iodine I 131 Tositumomab Therapeutic Regimen
Intervention description: Patients will receive unlabeled Tositumomab (450 mg) followed by Tositumomab (35 mg) which has been trace-labeled with 5 mCi of Iodine-131 (dosimetric dose). Whole body counts using a gamma camera will be obtained 3 times between Days 0 and 7 following the dosimetric dose to determine a patient-specific mCi dose of Iodine-131 calculated to deliver the desired total body dose of radiation (either 65 cGy or 75 cGy). The therapeutic dose is administered 7-14 days after the dosimetric dose. Patients will receive unlabeled Tositumomab (450 mg) followed by Tositumomab (35 mg) labeled with the patient-specific dose of Iodine-131 (median dose in previous studies was approximately 85 mCi). Patients who are obese will be dosed based upon 137% of their calculated lean body mass. Patients will be treated with thyroid blocking medication at least 24 hours prior to the dosimetric dose and continuing for 14 days following the therapeutic dose.
Intervention MeSH terms: Tositumomab I-131
Phase: Phase 2
Study type: Interventional
Enrollment: 765.0
Sex: All
Minimum age: 18 Years
Keywords: expanded access study; refractory low-grade non-Hodgkin's Lymphoma; Bexxar®; Iodine I 131 Tositumomab; EAP; relapsed low-grade non-Hodgkin's lymphoma

Summary:

      This is a single arm, multi-center, expanded access study of Iodine I 131 Tositumomab
      (BEXXAR) therapeutic regimen for patients with relapsed or refractory low-grade or
      transformed low-grade non-Hodgkin's B-cell lymphoma. The primary objective is to make Iodine
      I 131 Tositumomab more broadly available to patients. Secondary endpoints will be to obtain
      additional safety and efficacy information for this treatment regimen. Post study drug
      administration follow-ups will continue for up to ten years. These will include blood-work
      and adverse event assessments for 13 weeks post dosing, patient response evaluations at Week
      13, Months 6, 12, 18, 24, and Long-Term Follow-ups every 6 months until the elapse of 5 years
      from the dosimetric dose and then annually thereafter through year 10. Thyroid function will
      be monitored annually during Long-term follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed diagnosis of low- grade NHL or transformed low-grade NHL
             (tumor must be CD 20 positive).

          -  Prior treatment with at least one chemotherapy regimen and have relapsed or
             progressed, or failed to achieve an objective response on last chemotherapy regimen.

          -  Karnofsky performance status of at least 60% and anticipated survival of at least 3
             months.

          -  Absolute granulocyte of >/= 1,500/mm3.

          -  Platelet count of >/= 100,000/mm3, and not require sustained support of hematopoietic
             cytokines, or transfusion of blood products.

          -  Adequate renal function (i.e., <1.5x Upper Limit of Normal), and hepatic transaminases
             (AST <5 times ULN).

          -  Signed IRB/IEC-approved informed consent.

        Exclusion Criteria:

          -  Patients with a mean of >25% of the intratrabecular marrow space involved with
             lymphoma.

          -  Patients who received cytotoxic chemotherapy, radiation therapy, immunotherapy, or
             cytokine treatment within 4 weeks prior to study entry (6 weeks for nitrosurea
             compounds) or who exhibit persistent clinical evidence of toxicity.

          -  Patients who have undergone stem cell or bone marrow transplant, active obstructive
             hydronephrosis, active infection, New York Heart Association Class III or IV heart
             disease or other serious illness that would preclude evaluation.

          -  Known HIV infection.

          -  Pregnant or nursing patients.

          -  Patients with prior malignancy other than lymphoma, except for adequately-treated skin
             cancer, in-situ cervical cancer, or cancer for which the patient has been disease-free
             for 5 years.

          -  Patients with progressive disease within 1 year of irradiation arising in a field that
             has been previously irradiated with more than 3500 cGy.

          -  Patients who received prior radioimmunotherapy, known brain or leptomeningeal
             metastases, HAMA positivity.

          -  Patients who are receiving either approved or non-approved (through another protocol)
             anti-cancer drugs or biologics.