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Study for Children and Adolescents with Recurrent or Relapsed Solid Tumors Using Lutetium (177Lu) Oxodotreotide and Olaparib

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What is this study about?

This clinical trial is focused on treating children and adolescents with recurrent or relapsed solid tumors that have a specific feature called somatostatin receptors. These tumors have returned or persisted after initial treatment. The study will use a combination of two treatments: Lutathera and olaparib. Lutathera is a solution given through an infusion, which means it is delivered directly into the bloodstream. It contains a substance called lutetium (177Lu) oxodotreotide, which targets the somatostatin receptors on the tumors. Olaparib is a type of medication known as a PARP inhibitor, and it is taken orally in the form of film-coated tablets. PARP inhibitors work by interfering with the tumor cells’ ability to repair themselves, which can help to stop their growth.

The purpose of this study is to evaluate how effective the combination of Lutathera and olaparib is in treating these types of tumors. Participants in the study will receive these treatments every eight weeks. The study is designed to observe the response of the tumors to this treatment combination over time. The trial is open-label, meaning both the researchers and participants know which treatments are being administered. This study is specifically for young patients, ranging from 18 months to 18 years old, who have tumors that show a positive uptake on a special type of scan called SSTR-PET. This scan helps to identify the presence of somatostatin receptors on the tumors.

Throughout the study, the main focus will be on observing the tumors’ response to the treatment, which will be assessed using a standard method called RECIST. This method categorizes the response as complete, partial, stable, or progressive. The study aims to provide valuable information on the potential benefits of combining Lutathera and olaparib for treating these challenging cases of solid tumors in young patients.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the presence of recurrent or relapsed solid tumors that express somatostatin receptors.

A positive SSTR-PET scan is required, which shows the tumor’s uptake of a specific marker. This scan must have been performed within the last three months.

2 treatment cycle preparation

Before starting the treatment cycle, a series of tests are conducted to ensure adequate organ function. These tests include blood tests to check hemoglobin levels, white blood cell count, and other important health indicators.

The ability to swallow tablets is also assessed, as this is necessary for the administration of one of the medications.

3 administration of lutetium (177lu) oxodotreotide

The first medication, Lutathera 370 MBq/mL solution for infusion, is administered as an infusion. This involves receiving the medication through a vein over a period of time.

This step is part of a treatment cycle that occurs every 8 weeks.

4 administration of olaparib

Following the infusion, Lynparza 150 mg film-coated tablets are taken orally. The dosage and frequency are determined by the study protocol.

This medication is a PARP inhibitor, which helps to prevent cancer cells from repairing themselves.

5 monitoring and evaluation

Throughout the study, regular monitoring is conducted to evaluate the response to treatment. This includes imaging tests and assessments of tumor size and activity.

The primary goal is to observe changes in the tumor, categorized as complete response, partial response, stable disease, or progressive disease.

6 completion of treatment cycle

Each treatment cycle is completed every 8 weeks, after which the process is repeated as necessary based on the study’s schedule and the patient’s response.

The study is estimated to continue until August 2029, with regular assessments to ensure the safety and effectiveness of the treatment.

Who Can Join the Study?

  • Age: Must be between 18 months and 18 years old at the time of the initial diagnosis.
  • Diagnosis: Must have relapsed or refractory solid tumors that show positive uptake on a special scan called SSTR-PET. This scan should be done within the last three months before joining the study.
  • Performance Status: Must have a performance status of at least 50% on a scale that measures how well the patient can perform daily activities. This is measured by the Lansky scale for those under 16 years old and the Karnofsky scale for those 16 years and older.
  • Life Expectancy: Must have a life expectancy of at least 3 months.
  • Ability to Swallow: Must be able to swallow tablets.
  • Adequate Organ Function: Must have proper organ function as shown by specific blood tests within 28 days before joining the study. This includes:
    • Hemoglobin (Hb) level of at least 10 g/dL.
    • White blood cell count of at least 2500/μL.
    • Absolute Neutrophil Count (ANC) of at least 1000/μL.
    • Platelet count of at least 50,000/μL without recent transfusion.
    • Serum plasma creatinine within normal limits or an estimated kidney function (eGFR) of at least 60 mL/min/1.73m².
    • Total bilirubin within normal limits, with some allowance for patients with Gilbert’s Syndrome.
    • Liver enzymes (ALT or AST) within normal limits, with some allowance for patients with liver metastases.
    • Albumin level greater than 3.0 g/dL.
  • Pregnancy Test: Women who have started menstruating or are 12 years or older must have a negative pregnancy test.
  • Contraception: Patients who can have children must agree to use effective birth control during the study and for 4 months after the last dose of treatment.
  • Informed Consent: Must be able to understand and agree to sign a written consent form. If under 18, a parent or guardian must sign, and if between 12 and 17, the patient must also sign an assent form. If the patient turns 18 during the study, they must sign a consent form.
  • Recovery from Surgery: Must have adequately recovered from any major surgery before starting the study treatment.
  • Compliance: Must not have any psychological, family, social, or geographical issues that would prevent following the study protocol and schedule.

Who Cannot Join the Study?

  • Patients who do not have recurrent or relapsed solid tumors that express somatostatin receptors cannot participate. Recurrent means the cancer has come back after treatment, and relapsed means it has returned after a period of improvement. Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. Somatostatin receptors are specific proteins on the surface of some cells that can bind to a hormone called somatostatin.
  • Patients who are not children or adolescents are excluded. This means the study is only for young people.
  • Patients who are not able to follow the study procedures or take the study medications as required will not be able to participate.
  • Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate will be excluded.
  • Patients who are pregnant or breastfeeding cannot take part in the study.
  • Patients who are participating in another clinical trial at the same time will not be allowed to join this study.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Hospital Universitario Hm Monteprincipe Boadilla Del Monte Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
15.08.2024

Trial locations

Investigated drugs:

177Lu-DOTATATE (Lutathera®) is a type of targeted therapy used in this clinical trial. It is a radioactive drug that binds to somatostatin receptors on certain tumor cells. Once attached, it delivers radiation directly to the cancer cells, helping to destroy them while minimizing damage to surrounding healthy tissue. This therapy is being tested for its effectiveness in treating recurrent or relapsed solid tumors in children and adolescents.

Olaparib is a medication known as a PARP inhibitor. It works by blocking an enzyme that cancer cells use to repair their DNA. By inhibiting this enzyme, olaparib makes it harder for cancer cells to fix themselves, leading to their death. In this trial, olaparib is combined with 177Lu-DOTATATE to see if the combination is more effective in treating tumors that express somatostatin receptors.

Recurrent or relapsed solid tumors expressing somatostatin receptors – These are types of cancerous growths that have returned or persisted after initial treatment and are characterized by the presence of somatostatin receptors on their cells. These tumors can occur in various parts of the body and are known for their ability to evade the immune system and resist standard therapies. The presence of somatostatin receptors allows for targeted therapeutic approaches, as these receptors can be used to deliver specific treatments directly to the tumor cells. The progression of these tumors can vary, with some growing slowly while others may spread more rapidly. The behavior of these tumors often depends on their location, size, and the specific characteristics of the cancer cells involved.

Trial ID:
2024-512613-40-00
Protocol code:
LuPARPed-HM-2024
Trial Phase:
Human Pharmacology (Phase I) – Other

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