Selective Intra-arterial Injection of PRRT in Neuroendocrine Tumor Patients With Liver Metastases

• Status: Enrolling by invitation
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a safety study to determine the phase 1 starting dose of [90]Yttrium-DOTATOC when it is administered intravenously for patients with neuroendocrine tumors that have spread to the liver.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sandeep Laroia
• Collaborators: Holden Comprehensive Cancer Center; National Cancer Institute (NCI); National Institutes of Health (NIH)
• Treatments: Edotreotide; Octreotide

Criteria

Inclusion Criteria:

• Ability to understand and the willingness to provide informed consent

• Pathologically well-differentiated neuroendocrine tumor (i.e. grade 1 or grade 2).

• Primary tumor location should be known or believed to be midgut.

• At least one tumor in the liver that is positive with [68]Ga-DOTATATE (NETSPOT). Imaging must be performed within the past 6 months.

• Liver lesions not amendable to other therapies (surgery, ablation) and have progressed after treatment with octreotide/lanreotide and/or other treatments. (everolimus, sunitinib).

• Karnofsky performance status of at least 70

• Absolute neutrophil count of at least 1,000 cells/mm3

• Platelet count of at least 90,000 cells / mm3

• Total bilirubin ≤ 2 x the upper limit of normal when adjusted for age

• AST and ALT ≤ 5 x the upper limit of normal when adjusted for age

• Serum creatinine ≤ 1.2 mg/dl; if serum creatinine is >1.2 mg/dl nuclear GFR will used for potentially eligible participants.

• Agrees to contraception.

Exclusion criteria:

• Liver tumor involvement greater than 70% by cross sectional imaging

• Extra-hepatic visceral and osseous metastases

• Concomitant therapy for tumor (except for somatostatin analogs or bisphosphonates)

• Previous PRRT or other liver directed therapy within 12 months of consent

• Women who are pregnant, breast feeding or breast pumping.

• Another concurrent malignancy on active therapy

• Previous external-beam radiation therapy to a kidney (including scatter dose)

• Therapeutic investigational drug within 4 weeks of therapy.

• Subjects for whom, in the opinion of their physician, a 24-hour discontinuation of somatostatin analogue therapy represents a health risk.

• Sandostatin LAR injection within 4 weeks or lanreotide injection within 8 weeks of proposed therapy.

• Inability to lie down supine for study procedure.

• Reaction to IV contrast used for the angiogram.

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring hospitalization, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements