Monoclonal Antibody Therapy in Treating Patients With Leukemia

Phase 1

Completed

• Conditions: Lymphoma; Radiation Toxicity

• Registration Number: NCT00019227
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

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.

Detailed Description

OBJECTIVES:

* 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.

Study Timeline

• Study Start: 1996-10
• Study First Submitted: 2001-07-11
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2003-03
• Study Completion: 2006-07
• Last Update Submitted: 2013-06-19
• Last Update Posted: 2013-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support; 🇺🇸 Bethesda, Maryland, United States