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Clinical Trial · NCT03044977
Study to Evaluate the Safety of Combining Two Radionuclide Therapies to Treat Mid-gut Neuroendocrine Tumors
Overview
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.
Sponsor
University of Iowa
Phase
Early Phase 1
Contacts
David Bushnell, MD (STUDY_CHAIR)
ClinicalTrials.gov
NCT03044977Drug / Compound
DOTATOC
Isotope(s):
YTTRIUM-90
Radioisotope: Y-90
Theranostic Role: Therapeutic Agent, SPECT Imaging & PET Imaging
T1/2 (Half-Life): 2.7 Days
Decay Mode: BETA
Energy: max 2.2 MeV
Range: In Tissue: Avg 2.5 mm, Max 11 mm; In Air: 35 feet
Decay Daughters: Zr90 (Stable)
Status: FDA Approvals: SIR-SPHERES® (2000), THERASPHERES® (2021)
Target(s):
- SSTR2
Ligand Class: Peptides
Chelator: DOTA
MIBG
Isotope(s):
IODINE-131
Radioisotope: I-131
Theranostic Role: Therapeutic Agent & SPECT Imaging
T1/2 (Half-Life): 8 Days
Decay Mode: BETA, GAMMA
Energy: βeta max 0.6 MeV Gamma 364 keV
Range: In Tissue: 0.8 -2.1 mm
Decay Daughters: Xe131
Status: FDA Approval: 1951-First FDA Approved Radiopharmaceutical), AZEDRA® (2018)
Target(s):
- NET
Ligand Class: Small Molecules
Eligibility
Inclusion
- ≥1 tumor site must have demonstrated uptake equal to or greater than normal liver as documented by nuclear scan imaging
- * Ability to understand and the willingness to provide informed consent.
- Disease not amenable to curative intent treatment (primarily surgery) and in addition has shown either clinical or radiographic progression on all available (non-radionuclidic) therapies known to confer clinical benefit.
- A pathologically confirmed (histology or cytology) malignant neoplasm that is determined to be well-differentiated neuroendocrine tumor (i.e. grade 1 or grade 2). The primary tumor location should be known or believed to be midgut, or pheochromocytoma, or paraganglioma.
- SSTR positive sites as demonstrated by either SSTR2 positivity (2+ or 3+ intensity and greater than 10% tumor cell occupying the receptors) or a nuclear medicine scan utilizing 111In-DTPA-Phe3-Octreotide (Octreoscan™) or 68Ga-DOTA-tyr3-Octreotide within 12 months prior to anticipated C1D1 demonstrating SSTR positive tumor sites
Exclusion
- Women who are pregnant or breast feeding.
- * Patients who are considered a fall risk.
- Surgery, radiation or chemotherapy within 4 weeks of proposed step 1 start date.
- Prior peptide-receptor radiotherapy (PRRT).
- Investigational drug within 4 weeks of proposed step 1 start date.
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