XCancer

Study to Evaluate the Safety of Combining Two Radionuclide Therapies to Treat Mid-gut Neuroendocrine Tumors

Description:

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)

Government Study Link:

NCT03044977 - Click here to see study on

ClinicalTrials.gov

DOTATOC

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

MIBG

Isotope(s):
Target(s):
  • NET
Ligand Class: Small Molecules
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.