LMB-2 Immunotoxin in Treating Young Patients With Relapsed or Refractory Leukemia or Lymphoma
- Conditions
- LeukemiaLymphoma
- Registration Number
- NCT00085150
- Lead Sponsor
- National Cancer Institute (NCI)
- 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.
- 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 (i.e., \> 75% of the activity of 1 µg/mL 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Winship Cancer Institute of Emory University
🇺🇸Atlanta, Georgia, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Doernbecher Children's Hospital at Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
🇺🇸Bethesda, Maryland, United States