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Reduced Radiation + Chemotherapy for Medulloblastoma
Study Summary
This trial is testing how well reduced doses of radiation therapy to the brain and spine, plus chemotherapy, work in treating patients with a certain type of brain tumor.
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.Trial Design
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Who is running the clinical trial?
Media Library
- I am between 6 and 10 years old with a creatinine level of 1 mg/dL or less.My medulloblastoma is WNT type, confirmed by specific tests.My cancer has a CTNNB1 mutation.I am a woman able to have children and have a negative pregnancy test.My medulloblastoma is of the WNT type, not the LC/A type.I am not pregnant, as pregnancy could risk the trial's safety.My spinal fluid test for cancer cells is negative.I do not have an IQ of 55 or less, but I may have ADHD, dyslexia, or posterior fossa syndrome.I have recently been diagnosed with my condition.My cancer does not have MYC or MYCN abnormalities.My CSF test for cancer staging was done at the right time after surgery.My kidney function is normal or near normal.I am 13-15 years old with a creatinine level below 1.5 (male) or 1.4 (female).I am over 16 and my kidney function tests are within the normal range.My bilirubin levels are within normal range for my age.My blood counts meet the required levels for neutrophils, platelets, and hemoglobin.My kidney function is within the required range for my age and gender.My bilirubin levels are normal and my liver enzyme (ALT) is below 135 U/L.My cancer shows positive for beta-catenin.My hemoglobin level is at least 8.0 g/dL.My child is between 3 and 6 years old with a creatinine level of 0.8 mg/dL or less.I am between 10 and 13 years old with a creatinine level of no more than 1.2 mg/dL.My kidney function, measured by creatinine levels, is within the normal range.I can speak and understand English, French, or Spanish well enough to complete health and brain function tests.My tumor is less than 1.5 cm^2, confirmed by a special imaging review.My treatment will start within 36 days after my surgery.I am between 3 and 21 years old.I haven't had radiation or chemotherapy, only surgery or steroids.My cancer has not spread to my brain or spine, and I can undergo a lumbar puncture.My brain functions are normal.I have seizures but they are well controlled with medication.
- Group 1: Treatment (reduced radiation therapy and chemotherapy)
- 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
For what medical treatments is Cyclophosphamide usually prescribed?
"While often used to treat lymphoma, cyclophosphamide can also help patients with acute lymphoblastic leukemia (ALL), ovarian germ cell tumour, and brain cancer."
How many people have been asked to participate in this clinical trial?
"That is accurate, the listing on clinicaltrials.gov says that this study is open for enrollment. The trial was first posted on October 2nd, 2017 and has since been edited September 14th of this year. A total of 45 individuals are being sought across 100 different locations."
Are octogenarians able to participate in this research project?
"In order to take part in this particular study, patients must be between the ages of 3 and 21. Out of 435 clinical trials, this is one of the 1387 that specifically focuses on people over the age of 65."
Has the United States Food and Drug Administration cleared Cyclophosphamide for public use?
"While there is some evidence that Cyclophosphamide is safe, it has not been proven effective yet and thus received a 2."
Are new participants being recruited for this experiment?
"The study, which was posted on October 2nd 2017 and edited September 14th 2022, is looking for patients who match the given criteria."
Might I be able to enroll in this particular clinical trial?
"In order to meet the needs of this trial, researchers are looking for 45 young patients aged 3-21 that have medulloblastoma. Most importantly, these potential participants must meet the following requirements: They must be enrolled and ready to begin protocol therapy no more than 36 days after having definitive diagnostic surgery (day 0)."
Are there any other hospitals conducting this research in the city?
"This study is being conducted in several hospitals, with Alberta Children's Hospital in Calgary, Alberta, Carolinas Medical Center/Levine Cancer Institute in Charlotte, North carolina and New york Medical College in Valhalla, New York being a few of the 100 locations."
Could you please outline any other research that has been completed with Cyclophosphamide?
"There are presently 1637 active trials studying Cyclophosphamide, with 455 of those in Phase 3 Clinical Trials. The majority of these studies originate from Philadelphia, but there are 74031 locations where Cyclophosphamide clinical trials are taking place."
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