NCT01048086

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Iowa · Academic / Other
• Sex: All
• Age: 6 Months – 30 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Neuroblastoma
• Neuroendocrine Tumor

Interventions

Type	Name	Description
DRUG	Retinoic Acid	160 mg, given orally, divided BID on Days 1-4 of each cycle for 4 cycles. Each cycle will be six weeks in duration. Dose will be adjusted to 5.33 mg/kg/day divided BID for children \<12 kg.
DRUG	Placebo	Placebo will be given in the same manner as retinoic acid in capsules that look identical.

Timeline

• Start date: 2009-06-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2010-01-13
• Last updated: 2016-06-21

Locations

1 site across 1 country: United States