Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085150
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2004-06-10
Brief Title:
LMB-2 Immunotoxin in Treating Young Patients With Relapsed or Refractory Leukemia or Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Pediatric Phase I Trial of LMB-2 for Refractory CD25-Positive Leukemias and Lymphomas
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE LMB-2 immunotoxin can locate cancer cells and kill them without harming normal cells
PURPOSE This phase I trial is studying the side effects and best dose of LMB-2 immunotoxin in treating young patients with relapsed or refractory leukemia or lymphoma
PURPOSE This phase I trial is studying the side effects and best dose of LMB-2 immunotoxin in treating young patients with relapsed or refractory leukemia or lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of LMB-2 immunotoxin in pediatric patients with CD-25 positive relapsed or refractory leukemia or lymphoma
Determine the toxic effects of this drug in these patients
Determine the pharmacokinetics of this drug including the terminal elimination serum half-life area under the curve volume of distribution and relationship to disease burden in these patients
Secondary
Evaluate the immonogenicity of this drug in these patients
Determine response in patients treated with this drug
Determine changes in lymphocyte subsets immunoglobulin levels serum cytokines and soluble cytokine receptor levels in patients treated with this drug
OUTLINE This is a dose-escalation multicenter study
Patients receive LMB-2 immunotoxin IV over 30 minutes on days 1 3 and 5 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression neutralizing antibodies ie 75 of the activity of 1 µgmL of LMB-2 immunotoxin or unacceptable toxicity Patients achieving complete remission CR receive 2 additional courses beyond CR Patients with acute lymphoblastic leukemia also receive cytarabine and hydrocortisone intrathecally once monthly concurrent with restaging lumbar punctures
Cohorts of 3-6 patients receive escalating doses of LMB-2 immunotoxin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined a total of 12 patients are treated at that dose level
Patients are followed weekly for 1 month and then monthly thereafter
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 2-4 years
Primary
Determine the maximum tolerated dose of LMB-2 immunotoxin in pediatric patients with CD-25 positive relapsed or refractory leukemia or lymphoma
Determine the toxic effects of this drug in these patients
Determine the pharmacokinetics of this drug including the terminal elimination serum half-life area under the curve volume of distribution and relationship to disease burden in these patients
Secondary
Evaluate the immonogenicity of this drug in these patients
Determine response in patients treated with this drug
Determine changes in lymphocyte subsets immunoglobulin levels serum cytokines and soluble cytokine receptor levels in patients treated with this drug
OUTLINE This is a dose-escalation multicenter study
Patients receive LMB-2 immunotoxin IV over 30 minutes on days 1 3 and 5 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression neutralizing antibodies ie 75 of the activity of 1 µgmL of LMB-2 immunotoxin or unacceptable toxicity Patients achieving complete remission CR receive 2 additional courses beyond CR Patients with acute lymphoblastic leukemia also receive cytarabine and hydrocortisone intrathecally once monthly concurrent with restaging lumbar punctures
Cohorts of 3-6 patients receive escalating doses of LMB-2 immunotoxin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined a total of 12 patients are treated at that dose level
Patients are followed weekly for 1 month and then monthly thereafter
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 2-4 years
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-5903 | None | None | None |
| NCI-04-C-0168 | None | None | None |