Pharmacokinetics and Imaging of 212Pb-TCMC-Trastuzumab After Intraperitoneal Administration in Ovarian Cancer Patients

November 18, 2013

This article provides scientific data related to the first three patients who participated in AREVA Med’s clinical trial at the University of Alabama at Birmingham.

 

Journal:

CANCER BIOTHERAPY AND RADIOPHARMACEUTICALS

Volume 29, Number 1, 2014

© Mary Ann Liebert, Inc.

DOI: 10.1089/cbr.2013.1531

http://online.liebertpub.com/doi/pdfplus/10.1089/cbr.2013.1531

 

Article Title:

Pharmacokinetics and Imaging of 212Pb-TCMC-Trastuzumab After Intraperitoneal Administration in Ovarian Cancer Patients

 

Authors:

  • AREVA Med:  Eileen Banaga, Julien Torgue
  • UAB:  Ruby F. Meredith, Michael T. Azure, Sui Shen, Souheil Saddekni, Ronda Carlise, Patty Bunch, Daniel Yoder, and Ronald Alvarez

 

Abstract:

Purpose: Study distribution, pharmacokinetics, and safety of intraperitoneal (IP) 212Pb-TCMC-trastuzumab in patients with HER-2-expressing malignancy.

Experimental Design: IP 212Pb-TCMC-trastuzumab was delivered, after 4 mg/kg intravenous (IV) trastuzumab, to 3 patients with HER-2-expressing cancer who had failed standard therapies. Patients were monitored for toxicity and pharmacokinetics/dosimetry parameters.

Results: Imaging studies after 0.2 mCi/m2 (7.4MBq/m2) show little redistribution out of the peritoneal cavity and no significant uptake in major organs. Peak blood level of the radiolabeled antibody, determined by decay corrected counts, was < 23% injected dose at 63 hours; maximum blood radioactivity concentration was 6.3 nCi/mL at 18 hours. Cumulative urinary excretion was £6% in 2.3 half-lives. The maximum external exposure rate immediately post-infusion at skin contact over the abdomen averaged 7.67 mR/h and dropped to 0.67 mR/h by 24 hours. The exposure rates at the other positions monitored (axilla, chest, and femur) decreased as a function of distance from the abdomen. The data points correlate closely with 212Pb physical decay (T1/2 = 10.6 hours). Follow-up >6 months showed no evidence of agent-related toxicity.

Conclusions: Pharmacokinetics and imaging after 0.2 mCi/m2 IP 212Pb-TCMC-trastuzumab in patients with HER-2-expressing malignancy showed minimal distribution outside the peritoneal cavity, £ 6% urinary excretion, and good tolerance.

 

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