Fludarabine Monophosphate Followed by Iodine I 131 Tositumomab for Untreated Low-grade and Follicular Non-Hodgkin's Lymphoma
Inclusion Criteria:
- Patients must be age 18 years or older.
- Patients must have a histologically-confirmed diagnosis of low-grade or follicular
non-Hodgkin's B-cell lymphoma.
- Patients must have Ann Arbor stage III or IV extent of disease after completing
staging.
- Patients must have bi-dimensionally measurable disease. At least one lesion must
have both perpendicular diameters > 2 cm.
- Patients must have evidence that their tumor expresses the CD20 antigen by
immunohistochemistry or flow cytometry.
- Patients must have no previous treatment for NHL.
- Patients must have a Karnofsky performance status of at least 60% and an anticipated
survival of at least 3 months.
- Patients must have absolute granulocyte count greater than or equal to 1500 cells/mm3
and a platelet count > 100,000 cells/mm3 within 14 days of study entry and not
require sustained support with hematopoietic cytokines or transfusion of blood
products.
- Patients must have adequate renal and hepatic function.
- Patients must sign IRB approved informed consent form(s) prior to study entry.
Exclusion Criteria:
- Patients who received systemic steroids within 1 week of study entry, except patients
on maintenance steroid therapy for a non-cancerous disease.
- Patients with evidence of active infection requiring intravenous antibiotics 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 HIV Infection.
- Patients with known brain or leptomeningeal metastases.
- Patients who are pregnant or nursing. Patients of childbearing potential must
undergo a pregnancy test at screening and on the day fludarabine treatment is
started. Treatment is not to be administered until a negative result is obtained.
Males and females must agree to use effective contraception for 6 months following
the iodine I 131 tositumomab therapy.
- Patients with prior malignancy other than lymphoma, except for adequately-treated
skin cancer in situ cervical cancer, or other cancer for which the patient has been
disease-free for 5 years.
- Patients with hypersensitivity to fludarabine.
- Patients who are receiving either approved or non-approved (through another protocol)
anti-cancer drugs or biologics.
- Patients who are HAMA positive.
- Patients with previous allergic reaction to iodine. This does not include reacting
to intravenous iodine containing contrast materials.
Inclusion Criteria for Iodine I 131 Tositumomab Therapy
- Patients who completed 3 cycles of fludarabine.
- Patients must have absolute granulocyte count ≥ to 1500/mm3, platelet count of ≥
100,000/mm3 (≥ 150,000/mm3 if > 25% bone marrow involvement at restaging), and not
require sustained support with hematopoietic cytokines or transfusions with blood
products.
- Patients must have adequate renal and hepatic function.
Exclusion criteria for Antibody Therapy
- Patients with active obstructive hydronephrosis.
- Patients with evidence of active infection requiring intravenous antibiotics.
- Patients who are pregnant.