Phase I Open Label, Single Arm Escalation Trial to Evaluate the Biodistribution and Safety of BU-12 in Patients With Advanced Leukemia
- To determine the biodistribution of indium-111 BU-12 in patients with refractory CD19+
- To determine the maximum tolerated dose of yttrium Y 90 anti-CD19 antibody BU-12
- Determine the human anti-mouse antibody (HAMA) response.
- To define, preliminarily, the antitumor activity of yttrium Y 90 anti-CD19 antibody
OUTLINE: Patients receive yttrium Y 90 anti-CD19 antibody BU-12/indium-111 BU-12 IV over 60
minutes on day 0 and undergo whole-body imaging on days 0, 1, 3, 4, and 7. Patients also
undergo blood collection and bone marrow biopsy periodically for dosimetry calculations and
After completion of study treatment, patients are followed periodically for 2 years.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Biodistribution of indium-111 BU-12
Perform a whole body scan acquiring both anterior and posterior images at a speed of 10 cm/min (20 minute scan) using a medium energy collimator, a 256 x 1024 computer acquisition matrix and acquisition photo peak settings of 172 and 247 keV with 15% windows.
Immediately post infusion, 4-6 hours after infusion and Days 1, 3, 4 and 7 after infusion
Brenda Weigel, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|Masonic Cancer Center at University of Minnesota||Minneapolis, Minnesota 55455|