90Y DOTA/Retinoic Acid for Neuroblastoma and Neuroendocrine Tumor (NET)
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|ClinicalTrials.gov Identifier: NCT01048086|
Recruitment Status : Withdrawn (No patients were enrolled because the company that pledged the drug does not yet have it available.)
First Posted : January 13, 2010
Last Update Posted : June 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma Neuroendocrine Tumor||Drug: Retinoic Acid Drug: Placebo||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
|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.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01048086
|United States, Iowa|
|University of Iowa Hospitals and Clinics|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||M Sue O'Dorisio, MD, PhD||University of Iowa|