Phase I trial of anti-B4-blocked ricin in pediatric patients with leukemia and lymphoma

J Immunother. 2001 Nov-Dec;24(6):511-6. doi: 10.1097/00002371-200111000-00008.

Abstract

Monoclonal antibodies, specific for antigens expressed on lymphoid malignancies, which have been conjugated to toxins such as ricin, hold promise in the therapy of childhood leukemia and lymphoma. Anti-B4-blocked ricin (anti-B4-bR) is such an agent, and a phase I study of this agent was conducted in children with relapsed or refractory B-lineage leukemia and lymphoma. Anti-B4-bR was given as two 7-day continuous infusions separated by 7 days. Twenty patients were enrolled and 19 received the drug. Two dosage levels (30 and 40 microg/kg per day) were evaluated. Forty micrograms per kilogram per day was the maximally tolerated dose. Dose-limiting toxicity was capillary leak syndrome. Grade 3 reversible elevation in transaminases was also encountered. Human antimouse antibodies or human antiricin antibodies were detected in five patients. No complete remissions or partial remissions were seen.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Multicenter Study
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adolescent
  • Adult
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / immunology
  • Antineoplastic Agents / therapeutic use*
  • Burkitt Lymphoma / drug therapy*
  • Burkitt Lymphoma / immunology
  • Burkitt Lymphoma / mortality
  • Child
  • Child, Preschool
  • Female
  • Humans
  • Immunoconjugates / adverse effects
  • Immunoconjugates / immunology
  • Immunoconjugates / therapeutic use*
  • Infant
  • Lymphoma, B-Cell / drug therapy*
  • Lymphoma, B-Cell / immunology
  • Lymphoma, B-Cell / mortality
  • Male
  • Ricin / adverse effects
  • Ricin / immunology
  • Ricin / therapeutic use*

Substances

  • Antineoplastic Agents
  • Immunoconjugates
  • anti-B4 blocked ricin immunoconjugate
  • Ricin