Neuroendocrine and Nervous
System Tumor Trials

Study Title:  A Phase I, Open Label, Maximum Tolerated Dose-Finding Study to Evaluate the Safety and Tolerability of 90Y-DOTA-Octreotide Administered by Intravenous Infusion to Children with Refractory Somatostatin-Receptor Positive Tumors

Study Summary:
This is a study to evaluate the safety & tolerability of Octreother (90Y-DOTA-tyr3-octreotide) when used in children who have tumors with somatostatin receptors.  Tumors most likely to have somatostatin receptors include: brain tumors (medulloblastoma, supratentorial PNET, and astrocytomas) and neuroendocrine tumors (neuroblastoma, pheochromocytoma, carcinoid, and peripheral PNET).  The drug is administered in six-week cycles for a maximum of three doses.  Study procedures will include:  physicals, Octreoscan, CT or MRI, blood work, kidney function testing, echocardiogram, electrocardiogram bone marrow aspirate, lumbar puncture (if brain or spine tumor).  An overnight stay in the hospital is required on day of drug administration; weekly evaluations are required during intervals between drug doses and may be completed in your home community.   A complete physical and all listed evaluations are completed every six months for life.

Eligible children must meet the following conditions:

• Age 2 – 25 years
• Disease that is visible on Octreoscan
• Disease that has never been irradiated or has progressed despite radiation
• No full brain or spine radiation within 3 months of study drug administration
• No limited radiation within 4 weeks of study drug administration
• No surgery or chemotherapy within 4 weeks of study drug administration
• Bone marrow > 40% cellularity or >20% with stem cells stored
• Platelet count > 100,000   ANC >1,000  
• Normal heart, bone marrow and kidney function
• No pregnancy or breast-feeding

All information obtained from participants and from the laboratory studies will be treated as confidential medical records and will not be released with your identity attached.

Please note it is possible that neither patients nor their families will receive direct benefit from participating in this study. Treatment with this new drug may offer patients some control of their cancer.  However, this benefit cannot be promised nor the chance of benefit accurately predicted.

The director of this study is M. Sue O'Dorisio, MD PhD and the study coordinator is Stacy Michael, ARNP. You can let us know of your interest in participating in this study in two ways:

• Complete and submit the confidential on-line information form.
• Contact Stacy Michael, ARNP, study coordinator, by e-mail, stacy-michael@uiowa.edu or by telephone at 319-356-4826.

Thank you for considering this opportunity to assist us in our search to find new treatments for brain tumors and neuroendocrine tumors in children and young adults.