11 Participants Needed

Lutathera for Neuroendocrine Tumors

(NETTER-P Trial)

Recruiting at 12 trial locations
NP
Overseen ByNovartis Pharmaceuticals
Age: < 18
Sex: Any
Trial Phase: Phase 2
Sponsor: Advanced Accelerator Applications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is Lutathera safe for treating neuroendocrine tumors?

Lutathera, also known as Lutetium Lu-177 dotatate, is generally considered safe for treating neuroendocrine tumors, with most side effects being mild and reversible. However, there are potential risks of kidney, liver, and blood-related toxicities, and a small risk of developing a second cancer.12345

What makes Lutathera treatment unique for neuroendocrine tumors?

Lutathera is a unique treatment for neuroendocrine tumors because it is a targeted therapy that uses a radioactive substance to specifically target and bind to somatostatin receptors on tumor cells, delivering radiation directly to the cancer. This approach is different from traditional chemotherapy, which affects both cancerous and healthy cells, and it offers a new option for patients with limited treatment choices.36789

What data supports the effectiveness of the treatment Lutathera for neuroendocrine tumors?

Research shows that Lutathera (Lutetium [177Lu] oxodotreotide) is effective in treating well-differentiated neuroendocrine tumors by improving progression-free survival (the time during which the disease does not get worse), overall survival, and quality of life. It has been approved for use based on promising results from clinical trials, including the NETTER-1 trial, which demonstrated significant benefits for patients with certain types of neuroendocrine tumors.37101112

Who Is on the Research Team?

NP

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

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.
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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.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 2 weeks

Treatment

Participants receive 4 Lutathera treatments administered at 8-week intervals, with dosimetry and PK assessments during the first week after the 1st dose

32 weeks
4 visits (in-person) for Lutathera administration

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a short-term follow-up of 6 months and a long-term follow-up of 54 months

60 months

What Are the Treatments Tested in This Trial?

Interventions

  • Lutetium [177Lu] oxodotreotide/dotatate
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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: GEP-NET and PPGLExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Advanced Accelerator Applications

Lead Sponsor

Trials
37
Recruited
3,000+

Published Research Related to This Trial

In a study of 79 patients with progressive neuroendocrine tumors treated with Lu-DOTATATE, 13% showed a partial response and 64% had stable disease, with a median time to progression of 28 months overall.
The treatment was found to be safe, with only a few patients experiencing mild toxicity, including grade 1 haematotoxicity and nephrotoxicity, supporting its use as an effective option for managing these tumors.
Early efficacy of and toxicity from lutetium-177-DOTATATE treatment in patients with progressive metastatic NET.Pencharz, D., Walker, M., Yalchin, M., et al.[2019]
This study aims to evaluate the efficacy of four additional cycles of Lutathera® compared to two cycles in patients with progressive well-differentiated intestinal neuroendocrine tumors (NET), with a total of 146 patients participating.
The primary goal is to determine if the additional cycles can improve disease control rates over 6 months without increasing safety concerns, potentially leading to new treatment recommendations for extending patient survival and quality of life.
A prospective, randomized, phase II study to assess the schemas of retreatment with Lutathera® in patients with new progression of an intestinal, well-differentiated neuroendocrine tumor (ReLUTH).Deshayes, E., Assenat, E., Meignant, L., et al.[2022]
Lutetium-177-dotatate (177 Lu-dotatate) is an FDA-approved treatment for advanced somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (NETs), based on positive results from the NETTER-1 trial.
A case study presented shows that a patient with a grade 3 pancreatic neuroendocrine tumor and a BRCA1 germline mutation experienced a significant response to 177 Lu-dotatate, suggesting its potential efficacy even in more aggressive tumor types.
Homologous Recombination Repair Defect May Predict Treatment Response to Peptide Receptor Radionuclide Therapy for Neuroendocrine Tumors.Zhu, M., Bassam Sonbol, M., Halfdanarson, T., et al.[2022]

Citations

Early efficacy of and toxicity from lutetium-177-DOTATATE treatment in patients with progressive metastatic NET. [2019]
A prospective, randomized, phase II study to assess the schemas of retreatment with Lutathera® in patients with new progression of an intestinal, well-differentiated neuroendocrine tumor (ReLUTH). [2022]
Homologous Recombination Repair Defect May Predict Treatment Response to Peptide Receptor Radionuclide Therapy for Neuroendocrine Tumors. [2022]
Peptide receptor radionuclide therapy with 177Lu-DOTATATE for patients with somatostatin receptor-expressing neuroendocrine tumors: the first US phase 2 experience. [2022]
Phase 3 Trial of 177Lu-Dotatate for Midgut Neuroendocrine Tumors. [2022]
Lutetium Lu-177 Dotatate Flare Reaction. [2022]
Peptide receptor radionuclide therapy with 177Lu-DOTA-octreotate: dosimetry, nephrotoxicity, and the effect of hematological toxicity on survival. [2018]
[Radionuclide therapy for neuroendocrine tumours]. [2019]
Efficacy of [177Lu]Lu-DOTATATE in metastatic neuroendocrine neoplasms of different locations: data from the SEPTRALU study. [2023]
177Lu-Dotatate administration using an infusion pump or a peristaltic pump: comparison of two methods. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Targeted Therapy: New Radiolabeled Somatostatin Analogs to Treat Gastroenteropancreatic Neuroendocrine Tumors. [2019]
[68Ga-DOTATOC PET/CT for Diagnosing Neuroendocrine Tumors]. [2022]
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