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90Y DOTA/Retinoic Acid for Neuroblastoma and Neuroendocrine Tumor (NET)

Neuroblastoma Clinical Trial

Official title:
90Y-DOTA-tyr3-Octreotide With or Without Retinoic Acid for the Treatment of Neuroblastoma and Neuroendocrine Tumors in Children and Young Adults. A Randomized, Placebo Controlled Phase II Trial With Dosimetry Guided Dosing

Clinical Trial Summary

This study is for patients with neuroblastoma or a neuroendocrine tumor who have not been able to have standard therapy or have failed the first-line therapy. The purpose of this study is to assess the safety and effectiveness of the combination of retinoic acid and Onalta (Y-90-DOTA-tyr3-Octreotide) in treating neuroblastoma and neuroendocrine tumors.

Clinical Trial Description

This study builds on the promising results of the Phase I trial of 90Y-DOTA-tyr3-Octreotide in childhood solid tumors and the history of cis-Retinoic Acid (cis-RA) use in children with neuroblastoma. This study will combine these two agents in a randomized Phase II trial. The safety and feasibility of using individual dosimetry measurements to maximize the 90Y-DOTA-tyr3-Octreotide radiation dose to tumor while limiting the renal radiation dose to 23 Gy will be rigorously tested.

Fixed dosing will allow each subject to receive three cycles of 90Y-DOTA-tyr3-Octreotide at 50 mCi/m2. Dosimetry will be performed at each of these cycles; the combined dosimetry measurements will be utilized to determine whether or not a fourth cycle will be administered and, if so, what that dose will be. The administration of this additional cycle is conditional upon a) a subject not experiencing a dose-limiting toxicity during any previous cycle and b) meeting all criteria required at study initiation prior to the fourth dose. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01048086
Study type Interventional
Source University of Iowa
Contact
Status Withdrawn
Phase Phase 2
Start date June 2009
Completion date November 2013
View Details
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