Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma
This important study is for children and young people with neuroblastoma that has returned after treatment (relapsed) or isn't getting better with current medicines (refractory). Researchers are testing if adding a drug called eflornithine makes existing treatments more effective. The main treatments being studied are a combination of chemotherapy drugs (irinotecan and temozolomide) and an immunotherapy drug (dinutuximab). Eflornithine works by blocking chemicals that help cancer cells grow. The study aims to find out if this new combination leads to better results for patients and fewer side effects. We hope this research will help improve future treatments for neuroblastoma.
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ما هو موضوع هذه الدراسة؟
This clinical trial is designed for children and young people who have a type of cancer called neuroblastoma. Specifically, it's for those where the cancer has either returned after being treated (this is called relapsed neuroblastoma) or hasn't responded well to previous treatments (known as refractory neuroblastoma). Finding effective ways to treat these situations is really important, and this study aims to explore new possibilities.
The trial is looking at a combination of medicines. There are two main chemotherapy drugs called irinotecan and temozolomide, which work by stopping cancer cells from growing and spreading. There's also an immunotherapy drug called dinutuximab, which helps your body's own immune system fight the cancer. On top of these, the study is investigating a drug called eflornithine. Eflornithine works by blocking certain chemicals that cancer cells need to grow, so the hope is that adding it to the other medicines will make the treatment more powerful.
The main goal is to see if combining eflornithine with the other medicines leads to a better response from the cancer compared to just using the chemotherapy and immunotherapy drugs alone. Researchers will also be carefully watching for any side effects and how long patients stay well. The results from this study could help doctors decide on the best treatments for neuroblastoma in the future, giving hope to many families.
النقاط الرئيسية
- This study investigates new treatments for neuroblastoma that has returned or is difficult to treat.
- It tests if adding eflornithine to current medicines (chemo and immunotherapy) makes them more effective.
- The study aims to improve treatment outcomes and manage side effects.
- Participants will be randomly assigned to receive eflornithine or not.
- Regular hospital visits, treatments, and tests will be part of taking part.
- The results could help shape future treatments for neuroblastoma.
من قد يكون مؤهلاً؟
To join this study, you would need to have been diagnosed with neuroblastoma, and it must be either a high-risk type that has come back after treatment, or hasn't responded to previous treatments.
Doctors would need to confirm your diagnosis using special tests, and your cancer must show up on scans like MRI, CT, or MIBG. It's important that you are generally well enough to take part and that your body's organs (like your heart, liver, and kidneys) are working properly. There are also specific rules about how much time must have passed since your last cancer treatment.
This study is for children and young people from age one upwards. The doctors on the study will carefully check all your medical information to make sure this trial is the right and safest option for you.
هل يمكن أن تناسبك هذه الدراسة؟
أجب عن هذه الأسئلة السريعة لترى ما إذا كنت مؤهلاً. هذا دليل فقط - الفريق البحثي هو الذي يتخذ القرار النهائي.
- Do I have a confirmed diagnosis of high-risk neuroblastoma?
- Has my neuroblastoma returned after treatment, or is it not responding?
- Am I generally well enough to take part in a clinical trial?
- Are my scans (like MRI, CT, or MIBG) showing the cancer?
- Is my age between 1 year old and any age older?
ماذا يتضمن المشاركة؟
If you decide to take part, you would be randomly assigned to one of two groups: one group will receive the standard treatment combination (irinotecan, temozolomide, and dinutuximab) and the other group will receive the same combination plus the added drug eflornithine. This happens over treatment cycles, with each cycle lasting 21 days.
Throughout the study, you'll need to take some medicines by mouth, and others will be given through a drip (IV) into your vein. You'll have regular hospital visits for these treatments and check-ups. These visits will involve blood tests, scans (like MRI, CT, or PET), and sometimes bone marrow samples to see how the treatment is working. You might also be asked about any pain you experience. The treatment takes place over up to 6 cycles, which means it could last for several months. After the treatment period, there will be follow-up appointments to monitor your health. The medical team will explain all the details, including how long each visit might take and the total duration you'll be involved in the study.
المخاطر والفوائد المحتملة
المواقع (145)
- مستشفى الأطفال في ألاباماالرمز البريدي المؤكدبرمنغهام، الولايات المتحدة
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- Kaiser Permanente Downey Medical Centerالرمز البريدي المؤكدداوني، الولايات المتحدة
- Miller Children's and Women's Hospital Long Beachالرمز البريدي المؤكدلونغ بيتش، الولايات المتحدة
- مستشفى الأطفال لوس أنجلوسالرمز البريدي المؤكدلوس أنجلوس، الولايات المتحدة
- مركز سيدرز سيناي الطبيالرمز البريدي المؤكدلوس أنجلوس، الولايات المتحدة
- Valley Children's Hospitalالرمز البريدي المؤكدماديرا، الولايات المتحدة
- كايسر بيرماننتي-أوكلاندالرمز البريدي المؤكدأوكلاند، الولايات المتحدة
- مستشفى الأطفال في مقاطعة أورانجالرمز البريدي المؤكدأورانج، الولايات المتحدة
- Lucile Packard Children's Hospital Stanford Universityالرمز البريدي المؤكدبالو ألتو، الولايات المتحدة
- مركز جامعة كاليفورنيا ديفيس الشامل للسرطانالرمز البريدي المؤكدساكرامنتو، الولايات المتحدة
- Rady Children's Hospital - San Diegoالرمز البريدي المؤكدسان دييغو، الولايات المتحدة
أسئلة شائعة
What is neuroblastoma?
Neuroblastoma is a rare type of cancer that mostly affects young children. It develops from special nerve cells called neuroblasts.
لماذا هذه الدراسة مهمة؟
This study aims to find better treatments for neuroblastoma that has come back or is hard to treat, with the hope of improving patient outcomes.
What is a 'relapsed' or 'refractory' cancer?
Relapsed means the cancer has returned after treatment. Refractory means the cancer isn't responding well to current treatments.
هل سأحصل بالتأكيد على الدواء الجديد؟
Patients are randomly put into one of two groups, so you might or might not receive the eflornithine in addition to the standard drugs.
What are the main treatments involved?
The main treatments are chemotherapy (irinotecan, temozolomide) and immunotherapy (dinutuximab), with some patients also getting eflornithine.
كيفية معرفة المزيد
تحدث دائمًا إلى طبيبك العام أو الأخصائي قبل اتخاذ قرار بالمشاركة في دراسة.
نقاش
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