Phase I trial of 90Y-DOTATOC therapy in children and young adults with refractory solid tumors that express somatostatin receptors

Yusuf Menda, M. Sue O'Dorisio, Simon Kao, Geetika Khanna, Stacy Michael, Mary Connolly, John Babich, Thomas O'Dorisio, David Bushnell, Mark Madsen

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52 Scopus citations

Abstract

The purpose of this study was to conduct a phase I trial of 90Y-DOTATOC to determine the dose-toxicity profile in children and young adults with somatostatin receptor-positive tumors. Methods: A 3 x 3 design was used to determine the highest tolerable dose of 90Y-DOTATOC, with administered activities of 1.11, 1.48, and 1.85 GBq/m2/cycle given in 3 cycles at 6-wk intervals. An amino acid infusion was coadministered with the radiopharmaceutical for renal protection. Eligibility criteria included an age of 2-25 y, progressive disease, a positive lesion on 111In-diethylenetriaminepentaacetic acid-D-Phe1-octreotide scanning, a glomerular filtration rate of 80 mL/min/1.73 m2 or more, bone marrow cellularity of 40% or more or stored autologous hematopoietic stem cells, 60% or more on the Lansky Play Scale, and informed consent. Results: Seventeen subjects (age, 2-24 y) received at least 1 dose of 90Y-DOTATOC; diagnoses included neuroblastoma, embryonal and astrocytic brain tumors, paraganglioma, multiple endocrine neoplasia IIB, and neuroendocrine tumors. No dose-limiting toxicities and no individual dose reductions due to renal or hematologic toxicity were noted. No complete responses were observed; 2 subjects experienced partial response, 5 had minor responses, 6 experienced stable disease, 2 had progressive disease, and 2 withdrew. Conclusion: Peptide receptor radionuclide therapy with 90Y-DOTATOC is safe in children and young adults and demonstrated a 12% partial response plus 29% minor response rate in patients with somatostatin receptor-positive tumors. No dose-limiting toxicities were observed. The recommended phase II dosing is 3 cycles of 1.85 GBq/m2/dose of 90Y-DOTATOC coadministered with amino acids.

Original languageEnglish
Pages (from-to)1524-1531
Number of pages8
JournalJournal of Nuclear Medicine
Volume51
Issue number10
DOIs
StatePublished - Oct 1 2010

Keywords

  • Children
  • Radiolabeled peptide
  • Somatostatin
  • Therapy

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    Menda, Y., O'Dorisio, M. S., Kao, S., Khanna, G., Michael, S., Connolly, M., Babich, J., O'Dorisio, T., Bushnell, D., & Madsen, M. (2010). Phase I trial of 90Y-DOTATOC therapy in children and young adults with refractory solid tumors that express somatostatin receptors. Journal of Nuclear Medicine, 51(10), 1524-1531. https://doi.org/10.2967/jnumed.110.075226