Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002765
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
1999-11-01
Brief Title:
Immunotoxin in Treating Patients With Leukemia or Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PHASE I STUDY OF ANTI-TACFv-PE38 LMB-2 A RECOMBINANT SINGLE-CHAIN IMMUNOTOXIN FOR TREATMENT OF TAC-EXPRESSING MALIGNANCIES
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 Immunotoxins 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 LMB-2 immunotoxin in treating patients who have leukemia or lymphoma
PURPOSE Phase I trial to study the effectiveness of LMB-2 immunotoxin in treating patients who have leukemia or lymphoma
Detailed Description:
OBJECTIVES
Assess the therapeutic efficacy and toxicity of the recombinant immunotoxin LMB-2 an anti-Tac murine monoclonal antibody fragment conjugated to a truncated portion of Pseudomonas exotoxin in patients with Tac-expressing leukemias and lymphomas
Define the pharmacokinetics of LMB-2 including the terminal elimination serum half-life area under the curve and volume of distribution
Evaluate in a preliminary manner the immunogenicity of LMB-2 in these patients
Determine the effect of LMB-2 on various components of the circulating cellular immune system
OUTLINE This is a dose escalation study
Patients receive LMB-2 immunotoxin IV over 30 minutes on days 1 3 and 5 Treatment repeats every 15-21 days for up to 10 courses in the absence of disease progression neutralizing antibodies or unacceptable toxicity
Cohorts of 3-6 patients each receive escalating doses of LMB-2 immunotoxin until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 1 patient experiences dose limiting toxicity
PROJECTED ACCRUAL A maximum of 40 patients will be accrued for this study
Assess the therapeutic efficacy and toxicity of the recombinant immunotoxin LMB-2 an anti-Tac murine monoclonal antibody fragment conjugated to a truncated portion of Pseudomonas exotoxin in patients with Tac-expressing leukemias and lymphomas
Define the pharmacokinetics of LMB-2 including the terminal elimination serum half-life area under the curve and volume of distribution
Evaluate in a preliminary manner the immunogenicity of LMB-2 in these patients
Determine the effect of LMB-2 on various components of the circulating cellular immune system
OUTLINE This is a dose escalation study
Patients receive LMB-2 immunotoxin IV over 30 minutes on days 1 3 and 5 Treatment repeats every 15-21 days for up to 10 courses in the absence of disease progression neutralizing antibodies or unacceptable toxicity
Cohorts of 3-6 patients each receive escalating doses of LMB-2 immunotoxin until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 1 patient experiences dose limiting toxicity
PROJECTED ACCRUAL A maximum of 40 patients 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-T95-0042N | None | None | None |
| NCI-96-C-0064F | None | None | None |