drugset / Trial / NCT03044977
Study to Evaluate the Safety of Combining Two Radionuclide Therapies to Treat Mid-gut Neuroendocrine Tumors
Phase 0
Active not recruiting
20 enrolled
David Bushnell
Holden Comprehensive Cancer Center · collabNational Cancer Institute (NCI) · collabNational Institutes of Health (NIH) · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This study is designed to identify the best tolerated doses of \[131\]Iodine-MIBG and \[90\]Yttrium-DOTATOC when co-administered to treat midgut neuroendocrine tumors. These drugs (131I-MIBG, 90Y-DOTATOC) are radioactive drugs, known as radionuclide therapy. Currently, the safest and best tolerated doses of these drugs (when combined together) is unknown.
Timeline
- Start
- 2017-05-07
- Primary completion
- 2025-12
- Completion
- 2027-12
Publications
- Background Bushnell DL, Madsen MT, O'cdorisio T, Menda Y, Muzahir S, Ryan R, O'dorisio MS. Feasibility and advantage of adding (131)I-MIBG to (90)Y-DOTATOC for treatment of patients with advanced stage neuroendocrine tumors. EJNMMI Res. 2014 Dec;4(1):38. doi: 10.1186/s13550-014-0038-2. Epub 2014 Sep 10.
- Background Madsen MT, Bushnell DL, Juweid ME, Menda Y, O'Dorisio MS, O'Dorisio T, Besse IM. Potential increased tumor-dose delivery with combined 131I-MIBG and 90Y-DOTATOC treatment in neuroendocrine tumors: a theoretic model. J Nucl Med. 2006 Apr;47(4):660-7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 131I-MIBG | Protein / enzyme biologic | — | Intravenous |
| Subject | 90Y-DOTATOC | Peptide | — | Intravenous |