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Radiopharmaceutical

Lutathera for Neuroendocrine Tumors

Phase 2

Waitlist Available

Research Sponsored by Advanced Accelerator Applications

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Expression of somatostatin receptors confirmed by a somatostatin receptor imaging (SRI) modality within 3 months prior to enrollment, with tumor uptake observed in the target lesions more or equal to the normal liver uptake.

Patients from 12 to < 18 years of age at the time of enrollment.

Must not have

Sexually active male patients, unless they agree to remain abstinent or be willing to use effective methods of contraception.

Current spontaneous urinary incontinence.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 72 hours after the first lutetium [lu 177] dotatate dose

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer drug, Lutathera, on patients aged 12-18 with either GEP-NETs or PPGLs. The safety and dosage of the drug will be evaluated.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of Lutathera include nausea, vomiting, fatigue, low blood counts leading to increased infection risk or bleeding problems. Kidney damage and liver toxicity may also occur. Some might experience allergic reactions to the medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am between 12 and 17 years old.

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I am mostly self-sufficient and can do most of my daily activities.

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My PPGL cancer has spread or can't be removed by surgery.

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My GEP-NET is advanced, cannot be surgically removed, and is well-differentiated with a Ki-67 index of 20% or less.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a sexually active male willing to use contraception or remain abstinent.

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I experience involuntary urine leakage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 72 hours after the first lutetium [lu 177] dotatate dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 72 hours after the first lutetium [lu 177] dotatate dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 72 hours after the first lutetium [lu 177] dotatate dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Absorbed radiation doses in target organ

Incidence of adverse events (AEs) and lab toxicities after 1st Lutathera administration

Secondary study objectives

Calculated organ absorbed doses based on imaging radioactivity concentration data

Incidence of adverse events (AEs) during the long term follow-up

Incidence of adverse events (AEs) during the short-term follow-up

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: GEP-NET and PPGLExperimental Treatment1 Intervention

All eligible participants will receive Lutathera (7.4 GBq/200 mCi x 4 administrations every 8+/-1 weeks; cumulative dose: 29.6 GBq/800 mCi), with a concomitant administration of 2.5% Lysine - Arginine amino acid solution.

0 / 7Eligibility criteria met