title: Phase I trial of anti-B4-blocked ricin in pediatric patients with leukemia and lymphoma.
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.
authors.affiliation: Children's National Medical Center, Washington DC, USA.
authors.forename: P
authors.initials: P
authors.lastname: Dinndorf
authors.forename: M
authors.initials: M
authors.lastname: Krailo
authors.forename: W
authors.initials: W
authors.lastname: Liu-Mares
authors.forename: S
authors.initials: S
authors.lastname: Frierdich
authors.forename: P
authors.initials: P
authors.lastname: Sondel
authors.forename: G
authors.initials: G
authors.lastname: Reaman
mesh_terms: D000293:Adolescent; D000328:Adult; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D002051:Burkitt Lymphoma / Q000188:drug therapy* / Q000276:immunology / Q000401:mortality; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D018796:Immunoconjugates / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D007223:Infant; D016393:Lymphoma, B-Cell / Q000188:drug therapy* / Q000276:immunology / Q000401:mortality; D008297:Male; D012276:Ricin / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*
chemical_list: D000970:Antineoplastic Agents; D018796:Immunoconjugates; C117142:anti-B4 blocked ricin immunoconjugate; D012276:Ricin