Monoclonal Antibody Therapy in Treating Patients With Leukemia
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody plus pentetic acid calcium in patients with leukemia.
Drug: pentetic acid calcium
Radiation: yttrium Y 90 daclizumab
|Study Design:||Primary Purpose: Treatment|
|Official Title:||PHASE I/II STUDY OF TAC-EXPRESSING ADULT T-CELL LEUKEMIA (ATL) WITH YTTRIUM-90 (90Y)-RADIOLABELED HUMANIZED ANTI-TAC AND CALCIUM-DTPA|
|Study Start Date:||October 1996|
|Study Completion Date:||July 2006|
- 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 anti-Tac.
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 MTD.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00019227
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|Study Chair:||Thomas A. Waldmann, MD||NCI - Metabolism Branch;MET|