Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002681
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
1999-11-01
Brief Title:
Monoclonal Antibody Plus Interleukin-2 in Treating Patients With Leukemia or Lymphoma
Sponsor:
Roger Williams Medical Center
Organization:
Roger Williams Medical Center
Study Overview
Official Title:
Humanized Anti-Tac Antibody Therapy In Hodgkins Disease A Phase IbII Trial
Status:
COMPLETED
Status Verified Date:
2011-06
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 Interleukin-2 may stimulate a persons white blood cells to kill leukemia or lymphoma cells Combining these two therapies may be an effective treatment for leukemia and lymphoma
PURPOSE Phase III trial to study the effectiveness of monoclonal antibody therapy plus interleukin-2 in treating patients who have leukemia or lymphoma
PURPOSE Phase III trial to study the effectiveness of monoclonal antibody therapy plus interleukin-2 in treating patients who have leukemia or lymphoma
Detailed Description:
OBJECTIVES
Assess the safety and tolerability of a multidose regimen of humanized anti-Tac monoclonal antibody HAT and interleukin-2 IL-2 in patients with leukemia and lymphoma
Describe the pharmacokineticspharmacodynamics of HAT and IL-2 in a multidose schedule including serum half-life of free HAT area under the curve and volume of distribution
Evaluate the immunogenicity of HAT
Identify immunologic parameters that correlate with efficacy
Evaluate the preliminary efficacy of HAT in these patients
Monitor patients receiving indium-111-labeled HAT for circulating infused antibody for pharmacokinetics tumor imaging and bioactivity binding ability
OUTLINE Patients are stratified according to disease Hodgkins lymphoma vs acute myelogenous leukemia vs chronic myelogenous leukemia
Patients receive humanized anti-TAC monoclonal antibody HAT IV over 30 minutes on day 1 then IV over 30 minutes every 7 days and interleukin-2 subcutaneously daily Treatment continues for up to 1 year in the absence of disease progression unacceptable toxicity or development of neutralizing antibodies
Patients are followed weekly for 2 months
PROJECTED ACCRUAL A total of 25 patients with Hodgkins lymphoma and 14 each with AML and CML will be accrued for this study
Assess the safety and tolerability of a multidose regimen of humanized anti-Tac monoclonal antibody HAT and interleukin-2 IL-2 in patients with leukemia and lymphoma
Describe the pharmacokineticspharmacodynamics of HAT and IL-2 in a multidose schedule including serum half-life of free HAT area under the curve and volume of distribution
Evaluate the immunogenicity of HAT
Identify immunologic parameters that correlate with efficacy
Evaluate the preliminary efficacy of HAT in these patients
Monitor patients receiving indium-111-labeled HAT for circulating infused antibody for pharmacokinetics tumor imaging and bioactivity binding ability
OUTLINE Patients are stratified according to disease Hodgkins lymphoma vs acute myelogenous leukemia vs chronic myelogenous leukemia
Patients receive humanized anti-TAC monoclonal antibody HAT IV over 30 minutes on day 1 then IV over 30 minutes every 7 days and interleukin-2 subcutaneously daily Treatment continues for up to 1 year in the absence of disease progression unacceptable toxicity or development of neutralizing antibodies
Patients are followed weekly for 2 months
PROJECTED ACCRUAL A total of 25 patients with Hodgkins lymphoma and 14 each with AML and CML will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-H95-0732 | None | None | None |
| BIDMC-92020534 | None | None | None |
| NEDH-92020534 | None | None | None |
| BIDMC-FDR001054 | None | None | None |