Clinical Trial: BL22 Immunotoxin In Treating Young Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

Official Title: Pediatric Phase I Trial of BL22 for Refractory CD22-Positive Leukemias and Lymphomas

Brief Summary:

RATIONALE: BL22 immunotoxin can locate tumor cells and kill them without harming normal cells. BL22 immunotoxin may be effective in treating relapsed or refractory acute lymphoblastic leukemia and non-Hodgkin's lymphoma.

PURPOSE: This phase I trial is studying the side effects and best dose of BL22 immunotoxin in treating young patients with relapsed or refractory acute lymphoblastic leukemia or non-Hodgkin's lymphoma.


Detailed Summary:

OBJECTIVES:

Primary

  • Determine the toxic effects of BL22 immunotoxin in pediatric patients with relapsed or refractory CD22-positive acute lymphoblastic leukemia or non-Hodgkin's lymphoma.
  • Determine the maximum tolerated dose of this drug in these patients.
  • Determine the immunogenicity of this drug in these patients.
  • Determine the pharmacokinetics of this drug in these patients.

Secondary

  • Determine the in vitro cytotoxicity of this drug against lymphoblasts from patients with acute lymphoblastic leukemia.
  • Determine the therapeutic efficacy of this drug in inducing remissions in these patients.
  • Determine changes in lymphocyte subsets, immunoglobulin levels, serum cytokines, and soluble cytokine receptor levels in patients treated with this drug.

OUTLINE: This is a non-randomized, dose-escalation study.

Patients receive BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5 OR on days 1, 3, 5, 7, 9, and 11. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) or unconfirmed CR (CRu) receive 2 additional courses beyond CR or CRu for a maximum of 6 courses.

Cohorts of 3-6 patients receive escalating doses of BL22 immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
Sponsor: MedImmune LLC

Current Primary Outcome: assessment of efficacy, safety, pharmacokinetics, immunogenicity. [ Time Frame: end of study ]

Original Primary Outcome:

Current Secondary Outcome: Expansion of MTD [ Time Frame: end of study ]

Original Secondary Outcome:

Information By: MedImmune LLC

Dates:
Date Received: February 10, 2004
Date Started: January 2004
Date Completion: October 2008
Last Updated: December 21, 2007
Last Verified: December 2007