Expanded Access Study of Iodine I 131 Tositumomab for Relapsed/Refractory Low-Grade and Transformed Low-Grade Non-Hodgkin's Lymphoma
- 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
- 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.
- Patients with a mean of >25% of the intratrabecular marrow space involved with
- 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.