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Lorlatinib + Standard Therapy for Neuroblastoma
Study Summary
This trial is testing a new drug, lorlatinib, in combination with the standard treatment for neuroblastoma or ganglioneuroblastoma, compared to the standard treatment alone.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 665 Patients • NCT00567567Trial Design
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Who is running the clinical trial?
Media Library
- I have a condition where my bone marrow doesn't produce enough blood cells.I cannot receive targeted radiopharmaceutical therapy due to my health conditions.My cancer is in an advanced stage with a specific genetic change.I was diagnosed with a certain stage of cancer before it spread, and I haven't had chemotherapy.I am a child aged 10 to less than 13 years with a specific health measure.I have been diagnosed with neuroblastoma or ganglioneuroblastoma.I am a boy aged 13-15 with a score of 1.5 or a girl with a score of 1.4.My creatinine clearance rate is at least 1.7 (male) or 1.4 (female).I can safely undergo a procedure to collect stem cells from my blood.My tumor is stage L2 without MYCN amplification.My child was diagnosed with a specific type of cancer before it spread, and it has now progressed without treatment.I have high-risk disease with limited prior treatment or emergency care only.I was diagnosed between the ages of 1 and 30.My child is between 2 and 6 years old with a specific health measurement.My cancer shows a high level of MYCN gene activity.My neuroblastoma is stage M with specific features.My cancer is at a specific stage (L2) and has a certain genetic feature (MYCN amplified).I am not pregnant and can take a pregnancy test if needed.I am older than 547 days.My kidney function is normal or near normal.My child is between 1 and 2 years old with a required level.My bilirubin levels are within the normal range for my age.I am a child aged 6 to less than 10 years.
- Group 1: Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT)
- Group 2: Arm E (lorlatinib, chemotherapy, HSCT, EBRT)
- Group 3: Arm A (chemotherapy, HSCT, EBRT)
- Group 4: Arm D (chemotherapy, HSCT, EBRT)
- Group 5: Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Based on the information I have provided, can I join this test group?
"This study is investigating a treatment for ganglioneuroblastoma in patients that are between 365 days and 30 years old. A total of 658 individuals will be enrolled in the trial."
What types of diseases or conditions does Autologous Hematopoietic Stem Cell Transplantation commonly help?
"Autologous Hematopoietic Stem Cell Transplantation is a medical procedure with potential to cure malignant neoplasms. Additionally, it has shown efficacy in treating other conditions such as high risk neuroblastoma, kaposi's sarcoma aids related, and merkel cell cancer."
Are there other similar investigations to this one?
"As of now, there are 2386 open medical studies related to Autologous Hematopoietic Stem Cell Transplantation in 87 different countries. The first trial was sponsored by Alfacell and completed in 1997. That study only had 300 participants and only reached Phase 3 in terms of drug approval. In the 23 years since 1997, there have been 3657 trials in total."
Does the FDA sanction Autologous Hematopoietic Stem Cell Transplantation?
"Autologous hematopoietic stem cell transplantation is a phase 3 trial, meaning that there is some data supporting efficacy and multiple rounds of data supporting safety. Therefore, our team at Power estimates the safety of this treatment to be a 3."
What is the frequency with which Autologous Hematopoietic Stem Cell Transplantation has been used in previous clinical trials?
"The first clinical trial studying Autologous Hematopoietic Stem Cell Transplantation was completed in 1997 at Spectrum Health Hospital - Butterworth Campus. In total, there have been 3657 completed clinical trials as of today. There are 2386 trials that are ongoing, with a significant amount of these taking place in Saint Louis, Missouri."
Are individuals below the age of 80 allowed to participate in this experiment?
"As this study only accepts participants that meet specific eligibility requirements, the minimum age an individual can be is 365 days old, with a maximum age of 30."
How many guinea pigs are testing this new drug?
"In order to carry out this research, 658 willing participants that meet the necessary requirements are needed. Patients have the opportunity to take part in this study at different sites such as Washington University School of Medicine in Saint Louis, Missouri and University of Minnesota/Masonic Cancer Center in Minneapolis, Minnesota."
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