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Pomalidomide for Medulloblastoma
Study Summary
This trial will study whether the drug pomalidomide is effective, safe, and tolerated in children and young adults with certain types of brain tumors that have come back or are progressing.
- Medulloblastoma
- Brain Tumor
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2015 Phase 2 trial • 36 Patients • NCT02011113Trial Design
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Who is running the clinical trial?
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- You (or your parent/legal guardian) must sign a form saying you understand and agree to participate in the study before any tests or procedures are done.You have had cancer before, except for certain types of brain tumors.You have a medical condition or mental health condition that could stop you from taking part in the study according to the investigator's opinion.You have a condition that may make it difficult to understand the results of the study.You have been diagnosed with a tumor, which has been confirmed by a biopsy or imaging tests. If you have a tumor called DIPG and it looks like DIPG on an MRI, you don't need a biopsy to confirm it.One of your close family members has an inherited bleeding disorder.You need to have an MRI of your brain and spine before the treatment starts. If you are taking steroids, the MRI should be taken while you are on a stable or decreasing dose for at least 5 days.You are physically able to perform daily activities without assistance with a performance score of 50 or higher.Your blood must have a minimum number of infection-fighting cells called neutrophils.You have already gone through one treatment, but it did not cure your condition.You have a type of brain tumor (high-grade glioma, medulloblastoma, ependymoma or diffuse intrinsic pontine glioma) that has come back or is getting worse. However, if you have a tumor related to neurofibromatosis type 1 (NF-1), you may still be eligible if you meet all the other requirements.You are between the ages of 1 and 20 and need a parent or guardian's permission to participate.You have a tumor that can be measured on an MRI scan. The tumor must be big enough to be seen on at least two MRI slices.Your platelet count needs to be at least 100,000/mm³ without needing a platelet transfusion in the past 7 days.You have already tried at least one standard treatment (or the most commonly used treatment if there isn't a standard one), and there are no more options for a complete cure.You cannot have been treated with pomalidomide before. If you have been treated with other similar drugs like thalidomide or lenalidomide, you may still be eligible as long as you did not experience any significant negative side effects.
- Group 1: Pomalidomide
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
In how many different medical clinics is this medical study being run today?
"Yes, there are 7 enrolling patients for this study. Some of the locations where you can take part in this trial include Stanford University Cancer Center in Stanford, University of Florida in Gainesville, and National Cancer Institute in Chicago."
Are there any positions left in this clinical trial for new participants?
"This particular trial is not accepting patients at this time, however there are 556 other trials for medulloblastoma and 88 studies involving Pomalidomide that are."
Would I be able to join this clinical study?
"This study is looking for 53 participants aged 1-21 who currently have medulloblastoma. In addition to meeting the age requirements, patients must also meet the following criteria: -Subject (when applicable, parental/legal representative) must understand and voluntarily sign an ICF/IAF prior to any study-related assessments/procedures being conducted.-Subject has received at least one prior standard therapy (or generally accepted upfront therapy if no standard exists) and have no known curative therapy.-Subject has Karnofsky (age ≥ 16 years) or Lansky (age < 16 years)"
How many people are enrolled in this trial?
"Right now, this particular clinical trial is not looking for new patients to enroll. The first posting was on August 22nd, 2017 and the most recent update occurred on September 28th, 2022. There are 556 other trials related to medulloblastoma that are actively recruiting and 88 for Pomalidomide if you're interested in alternative studies."
Is this research only seeking out people who are 45 and older?
"The age bracket for this study is 1-21 years old."
Is there a significant body of research on Pomalidomide?
"At this time, there are a total of 88 clinical trials involving Pomalidomide with 10 being in Phase 3. The largest concentration of these studies is based in Houston, Texas; however, there are 2773 locations running trials for Pomalidomide globally."
Is Pomalidomide a danger to patients?
"While Pomalidomide has shown some efficacy in clinical trials, there is currently not enough data to support its use. Consequently, it received a score of 2."
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