PHASE I/II STUDY OF TAC-EXPRESSING ADULT T-CELL LEUKEMIA (ATL) WITH YTTRIUM-90 (90Y)-RADIOLABELED HUMANIZED ANTI-TAC AND CALCIUM-DTPA
- Determine the maximum tolerated dose of yttrium Y 90 daclizumab (90Y daclizumab) when
combined with pentetic acid calcium in adults with Tac-expressing T-cell leukemia.
- Determine the therapeutic efficacy and toxicity of this regimen in these patients.
- Monitor patients treated on this regimen for circulating infused antibody (free and
labeled) and for the serum concentration of soluble interleukin-2 receptor.
- Evaluate, in a preliminary manner, the immunogenicity of daclizumab.
- Determine the effect of 90Y daclizumab on various components of the circulating
cellular immune system.
- Determine whether there is additional urinary excretion of yttrium Y 90 when compared
to that observed previously in patients treated without pentetic acid calcium.
OUTLINE: This is a dose escalation study of yttrium Y 90 daclizumab (90Y daclizumab).
Patients receive 90Y daclizumab IV over 2 hours on day 1 and a fixed dose of pentetic acid
calcium IV over 5 hours for 3 days. Treatment repeats every 6 weeks for a maximum of 9
courses in the absence of disease progression or circulating antibodies to humanized
Cohorts of 3-6 patients receive escalating doses of 90Y daclizumab until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 6 patients experience dose limiting toxicities. Additional patients are treated at the
Patients are followed at 4-6 weeks.
PROJECTED ACCRUAL: Up to 15 patients will be accrued for the phase I portion of the study. A
total of 30 patients will be accrued for the phase II portion of the study.
Primary Purpose: Treatment
Thomas A. Waldmann, MD
NCI - Metabolism Branch;MET
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|