Yttrium-90 DOTA-TOC Intra-arterial (IA) Peptide Receptor Radionuclide Therapy (PRRT) for Neuroendocrine Tumor

Completed · Early Phase 1

Conditions studied: Neuroendocrine Tumor

In brief

This is a prospective, pilot, single center, open-label study in patients with metastatic neuroendocrine tumor. Eligible participants will undergo baseline assessments at enrollment. Study participants will receive a one-time administration of 90Y-DOTA-TOC via the hepatic artery. Participants in the correlative sub-study will receive 68Ga-DOTA-TOC concurrent with the 90Y-DOTA-TOC dose, and undergo additional imaging and assessment.

Key facts

Study ID

NCT03197012

Run by

Thomas Hope

People needed

10

Starts

2017-07-01

Expected to finish

2019-05-31

Last updated by the study team

2020-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Biopsy proven neuroendocrine tumor, which is somatostatin receptor positive as demonstrated on somatostatin receptor Positron Emission Tomography (PET).
• All sites or origin are eligible.
• Functional and nonfunctional tumors are allowed. 2. Hepatic metastases on imaging meeting the following criteria:
• a. Liver-only or liver-dominant metastases, defined as: i. At least 10% liver parenchyma replacement by tumor, but less than 70% replacement of the hepatic parenchyma by tumor.
• For the imaging sub-study: at least one liver lesion must measure greater than 2 cm in size 2. For the imaging sub-study: treatment must only be performed using a single dose, and so arterial variant anatomy that would result in a split treatment will not be allowed ii. And, progression of the liver metastases demonstrated within the past twelve months defined as either:
• Appearance of any new liver lesion or
• 20% increase in size of at least one liver lesion. iii. Presence of low-volume extrahepatic lesions (including primary tumor) is allowed if they are stable and asymptomatic.
• b. SUVmax on 68Ga-DOTA-TOC PET of the liver metastases two times greater than the adjacent liver parenchyma.
• Not a candidate for surgical debulking.
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
• Age > 18.
• Ability to understand a written informed consent document, and the willingness to sign it.

You may not qualify if…

• Patients not capable of getting PET study due to weight, claustrophobia, or inability to lie still for the duration of the exam.
• a. For patients in the imaging correlate sub-study: contraindication for undergoing MRI based on University of California, San Francisco (UCSF) Radiology guidelines.
• Contraindication to hepatic arteriography (e.g. hepatic artery dissection and/or thrombosis, uncorrectable coagulopathy, severe allergy to iodinated contrast, severe vascular disease precluding safe hepatic artery catheterization).
• Any patient receiving treatment with short-acting octreotide, which cannot be interrupted for 48 hours before and 24 hours after the administration of 90Y-DOTA-TOC, or any patient receiving treatment with octreotide long-acting release (LAR) or lanreotide, which cannot be interrupted for at least 4 weeks before the administration of 90Y-DOTA-TOC.
• a. Concurrent somatostatin receptor analog (SSA) allowed if progression has been documented and the SSA dose has been stable for at least two months. Long-acting SSA cannot be given within four weeks of treatment and short-acting SSA cannot be given with 48 hours of treatment. SSA therapy can restart one day after treatment.
• Interferon, everolimus (mTOR-inhibitors), sunitinib or other systemic therapies within 4 weeks prior to enrollment. Bevacizumab within 6 weeks prior to enrollment.
• Any liver directed treatment (surgery, radioembolization, chemoembolization, chemotherapy and radiofrequency ablation) within 12 weeks prior to enrollment.
• Any external beam radiation treatment for hepatic disease. Prior external beam radiation therapy to more than 25% of the bone marrow.
• a. Prior systemic PRRT treatment is allowed, if it was performed at least six months prior.
• Pregnancy or lactation. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation
• Impaired liver function
• aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT)) / alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase (SGPT)) > 3 x upper limit of normal (ULN).
• Total bilirubin >1.5 x ULN
• Serum albumin <3.0 g/dL unless prothrombin time is within the normal range.
• Thrombosis of the main portal vein
• Clinical evidence of ascites (trace ascites on imaging acceptable).
• Impaired bone marrow reserve
• Hb concentration < 8.0 g/dL;
• Total White Blood Cell count (WBC) <2x109/L (2000/mm3);
• Platelets <75x109/L (75x103/mm3).
• Creatinine clearance <50 mL/min calculated by the Cockroft Gault method.
• Known intracranial metastases.

Where it is running

• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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