Lutathera for Neuroendocrine Tumors

(NETTER-P Trial)

Recruiting at 12 trial locations

Overseen By Novartis Pharmaceuticals

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Advanced Accelerator Applications

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a multicenter, open-label, single-arm study to evaluate the safety and dosimetry of Lutathera in adolescent patients 12 to \<18 years old with somatostatin receptor positive GEP-NETs and PPGLs. The study will enroll at least 8 patients in the GEP-NET cohort and as many adolescents with PPGL as possible in the exploratory PPGL cohort.

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

Adolescents aged 12 to <18 with advanced or metastatic GEP-NETs or PPGLs that can't be surgically removed. They must have somatostatin receptor-positive tumors, a Karnofsky score >=50 or Lansky Play-Performance Scale score >=50, and parental consent. Excluded are pregnant/breastfeeding teens, those with certain medical conditions, uncontrolled diseases, inadequate lab values, not using contraception (if applicable), known drug allergies, and other malignancies.

Inclusion Criteria

My tests show my tumor has somatostatin receptors, similar to or more than my liver.

I am between 12 and 17 years old.

My parent or guardian and I understand and agree to participate in the study.

Exclusion Criteria

Breastfeeding female patients unless they accept to discontinue breastfeeding from the 1st dose until 3 months after the last administration of study drug.

Laboratory parameters: Estimated creatinine clearance calculated by the Cockroft-Gault method < 70 mL/min; Hb concentration <5.0 mmol/L (<8.0 g/dL); WBC <2x109/L; platelets <75x109/L; Total bilirubin >3 x ULN for age; Serum albumin <3.0 g/dL unless prothrombin time is within the normal range.

You cannot have participated in any other experimental treatments in the past 30 days.

Treatment Details

Interventions

• Lutetium [177Lu] oxodotreotide/dotatate (Radiopharmaceutical)

Trial Overview The trial is testing the safety and dosimetry of Lutathera in young patients with specific neuroendocrine tumors. It's an open-label study where all participants receive the same treatment without a comparison group. At least eight will be enrolled for GEP-NETs and as many as possible for PPGLs to assess how well they tolerate the drug and how it distributes in their bodies.

Participant Groups

Group I: GEP-NET and PPGL Experimental Treatment 1 Intervention

All eligible participants will receive Lutathera (7.4 GBq/200 mCi x 4 administrations every 8 weeks; cumulative dose: 29.6 GBq/800 mCi), with a concomitant administration of 2.5% Lysine - Arginine amino acid solution.

Who Is Running the Clinical Trial?

Advanced Accelerator Applications

Lead Sponsor

Trials

37

Recruited

3,000+