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Blood, 1 August 2004, Vol. 104, No. 3, pp. 642-648.
Prepublished online as a Blood First Edition Paper on April 20, 2004; DOI 10.1182/blood-2003-12-4264.
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Submitted December 15, 2003
Accepted March 7, 2004
Phase I Trial study of 131I-labeled chimeric 81C6 monoclonal antibody for the treatment of patients with non-Hodgkin's lymphoma
David A Rizzieri*, Gamal Akabani, Michael Zalutsky, R E Coleman, Scott D Metzler, James E Bowsher, Bonnie Toaso, Elizabeth Anderson, Anand Lagoo, Steven Clayton, Charles Pegram, Joseph O Moore, Jon P Gockerman, Carlos DeCastro, Cristina Gasparetto, Nelson J Chao, and Darell D Bigner
Medicine, Div. of Oncology & Stem Cell Transplant, Duke University Medical Center, Durham, NC, USA
Radiology, Div. of Nuclear Medicine, Duke University Medical Center, Durham, NC, USA
Pathology, Div. of Hematopathology, Duke University Medical Center, Durham, NC, USA
Pathology, Div. of Immunohistochemistry, Duke University Medical Center, Durham, NC, USA
* Corresponding author; email: rizzi003{at}mc.duke.edu.
We report a phase I study of pharmacokinetics, dosimetry, toxicity and response of 131I anti-tenascin chimeric 81C6 for the treatment of lymphoma. Nine patients received a dosimetric dose of 370 MBq (10mCi). Three patients received an administered activity of 1480 MBq (40mCi) and 2 developed hematological toxicity requiring stem cell infusion. Six patients received an administered activity of 1110 MBq (30mCi) and 2 developed toxicity requiring stem cell infusion. The clearance of whole-body activity was mono-exponential with a mean [range] effective half-life of 110 [90 - 136] hours and a mean effective whole-body residence time of 159 [130 - 196] hours. There was rapid uptake within the viscera; however, tumor uptake was slower. Activity in normal viscera decreased proportional to the whole body; however, tumor sites presented a slow clearance (T1/2 86 - 191 hours). The mean [range] absorbed dose to whole-body was 67 [51 - 89] cGy whereas the dose to tumor sites was 963 [363 - 1517] cGy. Despite lack of a 'blocking' antibody, 1 of 9 patients attained a complete remission and 1 a partial remission. These data demonstrate this radiopharmaceutical to be an encouraging agent for the treatment of lymphoma particularly if methods to protect the normal viscera are developed.
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