Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019227
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2001-07-11
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PHASE III STUDY OF TAC-EXPRESSING ADULT T-CELL LEUKEMIA ATL WITH YTTRIUM-90 90Y-RADIOLABELED HUMANIZED ANTI-TAC AND CALCIUM-DTPA
Status:
COMPLETED
Status Verified Date:
2003-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 III trial to study the effectiveness of radiolabeled monoclonal antibody plus pentetic acid calcium in patients with leukemia
PURPOSE Phase III 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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-96-C-0147K | None | None | None |