Immunotoxin in Treating Patients With Leukemia or Lymphoma

Phase 1

Completed

• Conditions: Lymphoma; Leukemia

• Registration Number: NCT00002765
• Lead Sponsor: National Cancer Institute (NCI)

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.

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.

Study Timeline

• Study Start: 1996-04
• Study First Submitted: 1999-11-01
• Status Verified: 2003-03
• Study First Submitted QC: 2003-05-05
• Study First Posted: 2003-05-06
• Last Update Submitted: 2015-04-28
• Last Update Posted: 2015-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Laboratory of Molecular Biology; 🇺🇸 Bethesda, Maryland, United States

Medicine Branch; 🇺🇸 Bethesda, Maryland, United States