TheranosticTrials.org

Clinical Trial · NCT04234568

Testing the Addition of an Anti-cancer Drug, Triapine, to the Usual Radiation-Based Treatment (Lutetium Lu 177 Dotatate) for Neuroendocrine Tumors

Overview

This phase I trial studies the side effects and best dose of triapine when given together with lutetium Lu 177 dotatate in treating patients with neuroendocrine tumors. Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and not harm normal cells. Giving triapine and lutetium Lu 177 dotatate together may work better to treat patients with neuroendocrine tumors.

Sponsor

National Cancer Institute

Phase

Phase 1

Contacts

Susanne M Arnold (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT04234568

Drug / Compound

DOTATATE

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

DOTATATE

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

DOTATATE

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

Eligibility

Inclusion

  • * Metastatic, histologically confirmed well-differentiated neuroendocrine tumor with positive dotatate scan (gallium-68 or copper-64) within 6 months. Lesions on dotatate scan (gallium-68 or copper-64 dotatate scan) will be considered positive if the maximum standard uptake value (SUVmax) is \> 2 times SUV mean of normal liver parenchyma
  • Failure of at least one prior systemic cancer treatment, including somatostatin analogs
  • No prior exposure to peptide receptor radionuclide therapy
  • Patients must have measurable disease per RECIST 1.1
  • Patients must have progressive disease based on RECIST criteria, version 1.1 evidenced with CT scans/MRI obtained within 24 months from enrollment

Exclusion

  • Patients with an inability to swallow oral medications or gastrointestinal disease limiting absorption of oral agents
  • Uncontrolled congestive heart failure (New York Heart Association \[NYHA\] III, IV)
  • Patients who have received prior external beam radiotherapy to more than 50% of bone marrow, as determined by a radiation medicine physicist who will calculate the volume of bone marrow exposure in prior radiotherapy portals divided by the volume of total bone marrow harboring tissues. This ratio must be less than 50 percent
  • * Patients who have had major surgical procedures in the prior 6 weeks
  • Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study