Lutathera for Neuroendocrine Tumors
(NETTER-P 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 4 Lutathera treatments administered at 8-week intervals, with dosimetry and PK assessments during the first week after the 1st dose
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
What Are the Treatments Tested in This Trial?
Interventions
- Lutetium [177Lu] oxodotreotide/dotatate
Find a Clinic Near You
Who Is Running the Clinical Trial?
Advanced Accelerator Applications
Lead Sponsor