Abstract | UNLABELLED: The purpose of this study was to conduct a phase I trial of (90)Y-DOTATOC to determine the dose-toxicity profile in children and young adults with somatostatin receptor-positive tumors. METHODS: A 3 × 3 design was used to determine the highest tolerable dose of (90)Y-DOTATOC, with administered activities of 1.11, 1.48, and 1.85 GBq/m(2)/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 (111)In-diethylenetriaminepentaacetic acid-D-Phe(1)-octreotide scanning, a glomerular filtration rate of 80 mL/min/1.73 m(2) 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: CONCLUSION:
Peptide receptor radionuclide therapy with (90)Y-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/m(2)/dose of (90)Y-DOTATOC coadministered with amino acids.
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Authors | Yusuf Menda, M Sue O'Dorisio, Simon Kao, Geetika Khanna, Stacy Michael, Mary Connolly, John Babich, Thomas O'Dorisio, David Bushnell, Mark Madsen |
Journal | Journal of nuclear medicine : official publication, Society of Nuclear Medicine
(J Nucl Med)
Vol. 51
Issue 10
Pg. 1524-31
(Oct 2010)
ISSN: 1535-5667 [Electronic] United States |
PMID | 20847174
(Publication Type: Clinical Trial, Phase I, Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
- Radiopharmaceuticals
- Receptors, Somatostatin
- 90Y-octreotide, DOTA-Tyr(3)-
- Octreotide
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Topics |
- Adolescent
- Adult
- Child
- Child, Preschool
- Female
- Humans
- Male
- Maximum Tolerated Dose
- Neoplasms
(metabolism, radiotherapy)
- Octreotide
(adverse effects, analogs & derivatives, pharmacokinetics, therapeutic use)
- Radiation Injuries
(diagnosis, etiology, metabolism)
- Radiopharmaceuticals
(adverse effects, pharmacokinetics, therapeutic use)
- Receptors, Somatostatin
(metabolism)
- Risk Assessment
- Young Adult
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