Retreatment Study of Patients With Non-Hodgkin's Lymphoma Who Have Previously Responded to Iodine-131 Anti B1 Antibody
Inclusion Criteria:
- Patients with histologically confirmed initial diagnosis of non-Hodgkin's B-cell
lymphoma
- Patients must have previously responded with a duration of response of at least 3
months to Iodine-131 Anti-B1 Antibody therapy
- Patients must have evidence that their tumor tissue had CD20 expression
- Patients must have performance status of at least 60% on the Karnofsky scale and an
anticipated survival of at least 3 months
- Patients must have absolute granulocyte count (ANC) greater than 1,500 cells/mm3 and
platelet count greater than 100,000 cells/mm3 within 14 days of study entry without
support of hematopoietic cytokines or transfusion of blood products
- Patients must have adequate renal (serum creatine less than 1.5 x upper limit of
normal) and hepatic function (total bilirubin less than 1.5 x upper limit of normal
and hepatic transaminases, AST and ALT, less than 5 x upper limit of normal) within
14 days of study entry
- Patients must have bi-dimensionally measurable disease with a least one lesion
greater than or equal to 2 cm x 2 cm by CT scan
- Patients must be at least 18 years of age
- Patients must give written informed consent and sign an Institutional Review
Board/Ethics Committee- approved informed consent form prior to study entry
Exclusion Criteria:
- Patients with more than 25% bone marrow involvement
- Patients who have received cytotoxic chemotherapy, radiation therapy,
immunosuppressants, or cytokine treatment within 4 weeks prior to study entry or who
exhibit persistent clinical evidence of toxicity. The use of systemic steroids much
be discontinued at least 1 week prior to study entry.
- Patients with active obstructive hydronephoresis
- Patients with evidence of active infection requiring IV antibiotics at 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 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 known HIV infection
- Patients with known brain or leptomeningeal metasteses
- Patients who are pregnant or nursing