Finding studies
Finding studies
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Lead
Fred Hutchinson Cancer Center
With
PRIMARY OBJECTIVES: I. To estimate the maximally tolerated dose of 131I-BC8 (anti-cluster of differentiation \[CD\]45) (iodine I 131 monoclonal antibody BC8) that can be delivered prior to autologous stem cell transplantation for patients with relapsed/refractory B-non-Hodgkin lymphoma (NHL), T-NHL, or Hodgkin lymphoma (HL). SECONDARY OBJECTIVES: I. To optimize the protein dose (antibody \[Ab\]) to deliver a favorable biodistribution in the majority of patients. II. To assess the radiation dose delivered to tumor sites and normal organs by the above therapy. III. To evaluate the dose-response relationship of radiation-dose to tumor and clinical response. IV. To estimate the overall and progression-free survival of the above regimen in such patients. V. To evaluate the toxicity and tolerability of the above therapy. VI. To evaluate the feasibility of delivering high-dose 131I-BC8 and autologous stem cell transplantation (ASCT) to B-Cell NHL, T-NHL, and HL patients. VII. To evaluate the ability to reduce infusion reactions via unlabeled BC8 preinfusion. OUTLINE: This is a dose-escalation study. Patients receive a dosimetric dose of iodine I 131 monoclonal antibody BC8 intravenously (IV) on day -20 and a therapeutic dose on day -11. Before day -20, patients may also receive up to 2 additional dosimetric doses of iodine I 131 monoclonal antibody BC8 IV approximately 1-2 weeks apart. Patients then undergo autologous stem cell transplantation on day 0. After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months and then annually thereafter.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
