Phase I/II Radioimmunotherapy of Non-Hodgkin's Lymphoma With Radiolabeled Humanized Immuno-LL2: Treatment With 90Y-hLL2 IgG
- Histological or cytological diagnosis of B-cell lymphoma, and has failed at least one
regimen of standard chemotherapy. (All histological grades of NHL will be eligible
for this trial.)
- Measureable via CT, with at least one lesion > or = 1.5cm in one or both dimensions.
(Splenic tumors in absence of other tumors will not qualify.)
- Radiological studies (ie - CT) must be performed within 4 weeks prior to study start.
- Acceptable tumor burden that will allow adequate follow-up and evaluation.
- Less that 25% bone marrow involvement, determined by bone marrow biopsy.
- Must observe the following washout periods:
At least 4 weeks beyond any major surgery. At least 4 weeks beyond any radiation therapy
to the index lesion, and has recovered from radiation-induced toxicity.
At least 4 weeks beyond chemotherapy and/or immunotherapy. At least 2 weeks beyond
corticosteriod(s) use and blood counts are with laboratory criteria.
- Must have Karnofsky score >70% (or equivalent, ECOG 0-2) with expected survival of at
least 6 months.
- Serum creatinine < or = 1.5mg/dl or creatinine clearance > or = 50ml/min.
- Serum bilirubin < or = 2mg/dl.
- Hemoglobin > or = 10 g/dl; WBC > or = 3000/mm3; granulocyte count > or = 150/mm3;
platelet count > or = 100,000/mm3 with out transfusions or cytokines for at least 30
days prior to study.
- Immunomedics ELISA assay of HahLL2 < 100ng/ml for those with prior history of
monoclonal antibody infusions.
- Cognizant informed consent.