Lutathera for Neuroendocrine Tumors

Recruiting in Palo Alto (17 mi)

Overseen byLisa Bodei

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?This study will look at whether it is practical and safe to give Lutathera directly into an artery of the liver (hepatic intraarterial infusion). The researchers will compare the effects of hepatic intraarterial infusion in the liver with the effects of the standard approach (intravenous infusion in the arm). The researchers will also determine whether Lutathera is effective against participants' cancer.

Eligibility Criteria

This trial is for adults with certain types of neuroendocrine tumors that have spread to the liver and are not suitable for surgery. Participants must have a positive somatostatin-receptor, measurable disease progression, and be in relatively good health with an ECOG performance status of 0 or 1. They should agree to use contraception and can't join if they've had certain prior treatments like radiolabeled somatostatin analogs or extensive chemotherapy.

Inclusion Criteria

I cannot undergo surgery to cure my condition, but past surgeries are okay if they were over 6 weeks ago.

A disease that can be measured using the RECIST 1.1 guidelines, with at least one dimension measuring 1.0 cm or more.

Any new skin lesion that appears should be evaluated by a healthcare professional.

+14 more

Exclusion Criteria

My kidney function is poor, with high creatinine or low filtration rate.

I have severe urinary incontinence that makes certain cancer treatments unsafe.

My liver is mostly affected by cancer, as confirmed by a radiologist.

+18 more

Participant Groups

The study tests Lutathera (177Lu-DOTATATE) delivered directly into the liver's artery versus standard intravenous infusion. It aims to determine which method is safer, more practical, and effective against cancer by comparing their effects on tumor growth.

1Treatment groups

Experimental Treatment

Group I: PRRT with 177Lu-DOTATATEExperimental Treatment1 Intervention

Patients will undergo a routine 68Ga-DOTATATE PET/CT. Patients with sufficient tumor uptake will be offered therapy with 177Lu-DOTATATE. The treatment regimen will consist of four administrations of 177Lu-DOTATATE-two intra-arterial followed by two intravenous, two months apart (+/- 2 weeks), with renal protective amino acid solution co-administration.