Phase 1 trial study of 131I-labeled chimeric 81C6 monoclonal antibody for the treatment of patients with non-Hodgkin lymphoma

Blood. 2004 Aug 1;104(3):642-8. doi: 10.1182/blood-2003-12-4264. Epub 2004 Apr 20.

Abstract

We report a phase 1 study of pharmacokinetics, dosimetry, toxicity, and response of (131)I anti-tenascin chimeric 81C6 for the treatment of lymphoma. Nine patients received a dosimetric dose of 370 MBq (10 mCi). Three patients received an administered activity of 1480 MBq (40 mCi), and 2 developed hematologic toxicity that required stem cell infusion. Six patients received an administered activity of 1110 MBq (30 mCi), and 2 developed toxicity that required stem cell infusion. The clearance of whole-body activity was monoexponential with a mean effective half-life of 110 hours (range, 90-136 hours) and a mean effective whole-body residence time of 159 hours (range, 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 (T(1/2), 86-191 hours). The mean absorbed dose to whole-body was 67 cGy (range, 51-89 hours), whereas the dose to tumor sites was 963 cGy (range, 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.

Publication types

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

MeSH terms

  • Animals
  • Antibodies, Monoclonal / pharmacokinetics
  • Antibodies, Monoclonal / toxicity*
  • Biological Transport
  • Biopsy
  • Bone Marrow / pathology
  • Female
  • Humans
  • Immunotoxins / pharmacokinetics
  • Immunotoxins / toxicity
  • Iodine Radioisotopes / pharmacokinetics
  • Iodine Radioisotopes / toxicity*
  • Lymph Nodes / pathology
  • Lymphoma, Non-Hodgkin / pathology
  • Lymphoma, Non-Hodgkin / radiotherapy*
  • Male
  • Mice
  • Patient Selection
  • Tenascin / analysis
  • Tissue Distribution
  • Tomography, X-Ray Computed

Substances

  • Antibodies, Monoclonal
  • Immunotoxins
  • Iodine Radioisotopes
  • Tenascin