Logo image
Back
Phase I trial of 90Y-DOTATOC therapy in children and young adults with refractory solid tumors that express somatostatin receptors
Journal article   Open access   Peer reviewed

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 and Mark Madsen
The Journal of nuclear medicine (1978), Vol.51(10), pp.1524-1531
10/2010
DOI: 10.2967/jnumed.110.075226
PMCID: PMC3753801
PMID: 20847174
url
https://doi.org/10.2967/jnumed.110.075226View
Published (Version of record) Open Access

Abstract

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. 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. Seventeen subjects (age, 2-24 y) received at least 1 dose of (90)Y-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. 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.
 Neoplasms - metabolism Radiopharmaceuticals - pharmacokinetics Octreotide - analogs & derivatives Risk Assessment Humans Radiation Injuries - diagnosis Child, Preschool Octreotide - adverse effects Male Octreotide - pharmacokinetics Octreotide - therapeutic use Radiation Injuries - etiology Young Adult Maximum Tolerated Dose Adolescent Adult Female Neoplasms - radiotherapy Radiopharmaceuticals - adverse effects Receptors, Somatostatin - metabolism Radiation Injuries - metabolism Child Radiopharmaceuticals - therapeutic use

Details

Metrics

20 Record Views
63 Times Cited - Web of Science
Logo image