#1 Clinical Trials Search in Europe

L-Threonine

This article summarizes several clinical trials investigating the use of lutetium-177 oxodotreotide, also known as Lutathera, for treating different types of cancer. Lutathera is a radioactive drug that targets certain proteins found on cancer cells. The trials are exploring its effectiveness and safety for conditions like neuroblastoma, neuroendocrine tumors, meningioma, and other cancers with specific receptors.

Table of Contents

What is Lutetium (177Lu) Oxodotreotide?

Lutetium (177Lu) oxodotreotide, also known by its brand name Lutathera, is an innovative radiopharmaceutical drug used in the treatment of various cancers[1]. This medication combines a radioactive isotope (lutetium-177) with a molecule that targets specific receptors on cancer cells.

The drug is known by several synonyms, including:[2]

  • 177Lu-DOTA-TYR3-OCTREOTATE
  • 177Lu-DOTATATE
  • Lutetium (177Lu) dotatate

How Does It Work?

Lutetium (177Lu) oxodotreotide works through a process called peptide receptor radionuclide therapy (PRRT). This treatment approach combines two key elements:

  1. A targeting molecule (peptide) that binds to specific receptors on cancer cells
  2. A radioactive isotope that delivers localized radiation to destroy cancer cells

In this case, the drug targets somatostatin receptors, which are often overexpressed in certain types of tumors, particularly neuroendocrine tumors[2]. Once the drug binds to these receptors, it delivers a concentrated dose of radiation directly to the cancer cells, helping to shrink tumors and slow disease progression.

What Conditions Can It Treat?

Lutetium (177Lu) oxodotreotide is being studied for the treatment of various cancers, including:

  • Gastroenteropancreatic neuroendocrine tumors (GEP-NETs): These are rare tumors that occur in the digestive system and pancreas[3].
  • Neuroblastoma: A type of cancer that develops from immature nerve cells, often affecting children[1].
  • Meningioma: Tumors that develop in the membranes surrounding the brain and spinal cord[4].

The drug is particularly useful for patients with advanced or metastatic disease, especially when other treatment options have been exhausted.

How is It Administered?

Lutetium (177Lu) oxodotreotide is typically administered as an intravenous infusion. The treatment is usually given in cycles, with patients receiving multiple doses over a period of several months[1].

In some cases, researchers are exploring alternative administration methods, such as intra-arterial hepatic infusion for patients with liver metastases from GEP-NETs[3]. This approach aims to deliver a higher concentration of the drug directly to liver tumors.

Efficacy and Clinical Trials

Several clinical trials are currently underway to evaluate the efficacy of Lutetium (177Lu) oxodotreotide in various cancer types:

  • A phase II trial is studying its use in children with relapsed or refractory high-risk neuroblastoma[1].
  • Another study is investigating its effectiveness in combination with the drug olaparib for children and adolescents with recurrent or relapsed solid tumors[5].
  • A randomized phase II trial is evaluating its potential in treating recurrent meningioma[4].

Early results from these trials suggest that Lutetium (177Lu) oxodotreotide may offer promising outcomes for patients with limited treatment options. However, more research is needed to fully understand its long-term efficacy and safety profile.

Potential Side Effects

As with any medical treatment, Lutetium (177Lu) oxodotreotide can cause side effects. Some potential adverse reactions include:

  • Nausea and vomiting
  • Fatigue
  • Decreased blood cell counts
  • Kidney problems
  • Hormonal imbalances

Patients undergoing treatment with this drug are closely monitored for these and other potential side effects[1]. Your healthcare team will work to manage any side effects that may occur during treatment.

Conclusion

Lutetium (177Lu) oxodotreotide represents an innovative approach to cancer treatment, offering hope for patients with advanced neuroendocrine tumors and other cancers that express somatostatin receptors. While more research is needed to fully understand its potential, early clinical trials suggest it may be a valuable addition to the cancer treatment arsenal.

As with any medical treatment, it’s essential to discuss the potential benefits and risks of Lutetium (177Lu) oxodotreotide with your healthcare provider to determine if it’s an appropriate option for your specific situation.

Trial Focus Patient Population Key Objectives Treatment Details
Neuroblastoma in children Children with relapsed or refractory high-risk neuroblastoma Assess dose and response to Lutathera Single agent Lutathera treatment
Neuroendocrine tumors Adults with neuroendocrine tumors grade I and II Effect of somatostatin analogues on tumor dose during treatment Lutathera with or without long-acting somatostatin analogues
Acute graft-versus-host disease Patients with steroid-resistant gastrointestinal acute graft-versus-host disease Safety and efficacy of apraglutide with standard therapy Apraglutide with steroids and ruxolitinib
Short bowel syndrome Adults with short bowel syndrome Long-term safety of apraglutide Open-label extension trial of apraglutide
Recurrent meningioma Adults with recurrent meningioma Efficacy of Lutathera vs standard care Randomized trial of Lutathera vs local standard of care
Liver metastases from neuroendocrine tumors Adults with gastroenteropancreatic neuroendocrine tumors and liver metastases Intra-arterial vs intravenous Lutathera administration Comparison of intra-arterial hepatic and intravenous Lutathera infusion

FAQ

  • What is Lutathera and how does it work? Lutathera (lutetium-177 oxodotreotide) is a radioactive drug that targets somatostatin receptors found on some cancer cells. It delivers radiation directly to the tumors to help shrink or control them.
  • What types of cancers are being studied with Lutathera in these trials? The trials are investigating Lutathera for neuroblastoma in children, neuroendocrine tumors, recurrent meningioma, and gastroenteropancreatic neuroendocrine tumors with liver metastases.
  • How is Lutathera administered in these studies? Lutathera is typically given as an intravenous infusion. One trial is also exploring intra-arterial hepatic infusion for liver metastases. The drug is usually given in multiple cycles over several weeks or months.
  • What are some of the main goals of these clinical trials? The trials aim to assess the safety, effectiveness, and optimal dosing of Lutathera for different cancers. They are measuring outcomes like tumor response, progression-free survival, overall survival, and quality of life.
  • Are there any notable side effects or risks with Lutathera treatment? Common side effects can include nausea, fatigue, and decreased blood cell counts. The trials are closely monitoring for any adverse events, especially related to radiation exposure. Proper kidney and liver function is important for patients receiving this treatment.

Ongoing Clinical Trials on L-Threonine

  • Study on Ketoanalogue Supplementation for Muscle Protection in Patients with Stage 4 and 5 Chronic Kidney Disease on a Low Protein Diet

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on the Effectiveness of Ketoanalogues in Preventing Muscle Loss in Patients with Nephrotic Syndrome

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Poland

  • Ketosteril Added to Usual Nutrition for Patients Starting Incremental Haemodialysis with Incremental Haemodialysis

    Not yet recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

Glossary

  • Lutetium-177 oxodotreotide (Lutathera): A radioactive drug that targets somatostatin receptors on cancer cells to deliver radiation therapy directly to tumors.
  • Somatostatin receptor (SSTR): A protein found on the surface of some cancer cells that can be targeted by certain drugs like Lutathera.
  • Neuroendocrine tumor: A type of cancer that begins in specialized cells called neuroendocrine cells, which have traits of both nerve cells and hormone-producing cells.
  • Neuroblastoma: A type of cancer that develops from immature nerve cells, most commonly occurring in young children.
  • Meningioma: A tumor that forms on membranes that cover the brain and spinal cord just inside the skull.
  • Gastroenteropancreatic neuroendocrine tumor (GEP-NET): A rare type of tumor that can develop in the pancreas or parts of the gastrointestinal tract.
  • RECIST criteria: Response Evaluation Criteria in Solid Tumors – a standard way to measure how well a cancer patient responds to treatment.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives with cancer without it worsening.
  • Overall survival (OS): The length of time from the start of treatment or diagnosis that patients are still alive.
  • Intra-arterial hepatic infusion: A method of delivering drugs directly to the liver through the hepatic artery.
  • PET scan: Positron Emission Tomography – an imaging test that uses a radioactive tracer to look for disease in the body.
  • SUVmax: Maximum Standardized Uptake Value – a measurement of how much radiotracer is taken up by tissue in a PET scan.

References

  1. http://clinicaltrials.eu/trial/study-of-lutetium-177lu-oxodotreotide-for-children-with-relapsed-or-refractory-high-risk-neuroblastoma/
  2. http://clinicaltrials.eu/trial/study-on-the-effect-of-octreotide-and-lanreotide-in-peptide-receptor-radionuclide-therapy-for-adults-with-neuroendocrine-tumors/
  3. http://clinicaltrials.eu/trial/study-of-intra-arterial-infusion-of-lutetium-177lu-oxodotreotide-for-adults-with-gastroenteropancreatic-neuroendocrine-tumors-with-liver-metastases/
  4. http://clinicaltrials.eu/trial/study-of-lutetium-177lu-oxodotreotide-for-patients-with-recurrent-meningioma-without-surgery-or-radiotherapy-options/
  5. http://clinicaltrials.eu/trial/study-for-children-and-adolescents-with-recurrent-or-relapsed-solid-tumors-using-lutetium-177lu-oxodotreotide-and-olaparib/