Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019032
Status:
COMPLETED
Last Update Posted:
2015-04-28
First Post:
2001-07-11
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Chronic Lymphocytic Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PHASE I STUDY OF T-CELL LARGE GRANULAR LYMPHOCYTIC LEUKEMIA USING THE MIK-BETA 1 MONOCLONAL ANTIBODY DIRECTED TOWARD THE IL-2R BETA SUBUNIT
Status:
COMPLETED
Status Verified Date:
2004-04
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 cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells
PURPOSE Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have chronic lymphocytic leukemia
PURPOSE Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have chronic lymphocytic leukemia
Detailed Description:
OBJECTIVES
Evaluate the toxicity of murine monoclonal antibody Mik-beta-1 MOAB Mik-beta-1 in patients with T-cell large granular lymphocytic leukemia associated with granulocytopenia anemia or thrombocytopenia
Determine the clinical response in patients treated with this drug
Assess the effect of this drug on the number of circulating CD3 CD8 expressing granular lymphocytes and the number of polymorphonuclear leukocytes red blood cells and platelets in this patient population
Monitor patients for the time course of decline in circulating infused MOAB Mik-beta-1 and for the production of human antibodies to IV infused murine MOAB Mik-beta-1
OUTLINE This is a dose-escalation study
Patients receive monoclonal antibody Mik-beta-1 MOAB Mik-beta-1 IV over 2 hours on days 1 4 7 and 10 Patients achieving a complete response CR or partial response PR may receive 1 additional course beginning no sooner than 4 weeks after completion of the first course in the absence of antibodies to MOAB Mik-beta-1 Treatment continues in the absence of disease progression unacceptable toxicity or severe allergic reaction
Cohorts of 3-6 patients receive escalating doses of MOAB Mik-beta-1 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 toxicity
Patients are followed at 6-10 days and at 4-6 weeks after therapy Patients with a PR or CR may be followed every 6 months for 2 years or until relapse All patients are followed for survival
PROJECTED ACCRUAL A maximum of 25 patients will be accrued for this study
Evaluate the toxicity of murine monoclonal antibody Mik-beta-1 MOAB Mik-beta-1 in patients with T-cell large granular lymphocytic leukemia associated with granulocytopenia anemia or thrombocytopenia
Determine the clinical response in patients treated with this drug
Assess the effect of this drug on the number of circulating CD3 CD8 expressing granular lymphocytes and the number of polymorphonuclear leukocytes red blood cells and platelets in this patient population
Monitor patients for the time course of decline in circulating infused MOAB Mik-beta-1 and for the production of human antibodies to IV infused murine MOAB Mik-beta-1
OUTLINE This is a dose-escalation study
Patients receive monoclonal antibody Mik-beta-1 MOAB Mik-beta-1 IV over 2 hours on days 1 4 7 and 10 Patients achieving a complete response CR or partial response PR may receive 1 additional course beginning no sooner than 4 weeks after completion of the first course in the absence of antibodies to MOAB Mik-beta-1 Treatment continues in the absence of disease progression unacceptable toxicity or severe allergic reaction
Cohorts of 3-6 patients receive escalating doses of MOAB Mik-beta-1 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 toxicity
Patients are followed at 6-10 days and at 4-6 weeks after therapy Patients with a PR or CR may be followed every 6 months for 2 years or until relapse All patients are followed for survival
PROJECTED ACCRUAL A maximum of 25 patients will be accrued for this 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-95-C-0054K | None | None | None |