90Y DOTA/Retinoic Acid for Neuroblastoma and Neuroendocrine Tumor (NET)
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.
Drug: Retinoic Acid
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Evaluate tumor response to 90Y-DOTA-tyr3-Octreotide alone and in combination with 13-cis retinoic acid for the treatment of children and young adults with recurrent, somatostatin-receptor positive tumors [ Time Frame: 6 weeks after last treatment ] [ Designated as safety issue: No ]
- Estimate and compare time to tumor progression and overall survival in the patients treated with 90Y-DOTA-tyr3-Octreotide alone and in combination with 13-cis retinoic acid. [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
|Experimental: Retinoic Acid||
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.
Other Name: 13-cis retinoic acid
|Placebo Comparator: Placebo||
Placebo will be given in the same manner as retinoic acid in capsules that look identical.
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.