Anti-B4-blocked ricin: a phase I trial of 7-day continuous infusion in patients with B-cell neoplasms.

• DOI: 10.1200/jco.1993.11.4.726
• Publication Date: 2017-02-23T13:42:24Z
• Authors: M L Grossbard; J M Lambert; V S Goldmacher; N L Spector; J Kinsella; L Eliseo; F Coral; J A Taylor; W A Blättler; C L Epstein
• Keywords: Bolus (digestion)

PURPOSE This phase I trial was undertaken to determine the maximum-tolerated dose (MTD) and dose-limiting toxicities (DLTs) of B-cell-restricted immunotoxin anti-B4-blocked ricin (anti-B4-bR) when it is administered by 7-day continuous infusion. PATIENTS AND METHODS Thirty-four patients with relapsed refractory B-cell neoplasms (26 non-Hodgkin's lymphoma [NHL], four chronic lymphocytic leukemia [CLL], acute lymphoblastic [ALL]) received infusion anti-B4-bR. Successive cohorts at least three were treated doses 10 70 micrograms/kg/d for 7 days increased each cohort. The initial (10, 20, 30 x days) also a bolus 20 micrograms/kg before beginning RESULTS MTD reached 50 days. DLTs National Cancer Institute Common Toxicity Criteria (NCI CTC) grade IV reversible increases in AST ALT, decreases platelet counts. Adverse reactions included fevers, nausea, headaches, myalgias, hypoalbuminemia, dyspnea, edema, capillary leak syndrome. Potentially therapeutic serum levels anti-B4-bR could be sustained 4 MTD. Two complete responses (CRs), partial (PRs), 11 transient (TRs) observed. CONCLUSION Anti-B4-bR can safely tolerable, neoplasms. Although occasional seen, future trials will use lower tumor burdens circumvent obstacle delivery bulk disease.