Your session is about to expire
← Back to Search
Alkylating agents
Reduced Radiation + Chemotherapy for Medulloblastoma
Phase 2
Waitlist Available
Led By Nicholas J Gottardo
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
6 to < 10 years of age: max serum creatinine 1 mg/dL (males and females)
Patients must be newly diagnosed and have: Eligibility confirmed by rapid central pathology and molecular screening review on APEC14B1: Classical histologic type (non LC/A) WNT medulloblastoma Positive nuclear beta-catenin by immunohistochemistry (IHC) Positive for CTNNB1 mutation Negative for MYC and MYCN by fluorescence in situ hybridization (FISH)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
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.
Who is the study for?
This trial is for young patients with a newly diagnosed brain tumor called WNT-driven medulloblastoma. Eligible participants must be between 3 and 22 years old, have good kidney and liver function, adequate blood counts, no prior tumor-directed therapy except surgery/corticosteroids, not pregnant or breastfeeding, agree to use contraception if applicable, and able to perform required language skills for assessments.Check my eligibility
What is being tested?
The study tests whether lower doses of radiation therapy to the brain/spine along with chemotherapy (cisplatin, vincristine sulfate, cyclophosphamide and lomustine) are effective in treating WNT-driven medulloblastoma while reducing late side effects like learning difficulties or hormone deficiencies.See study design
What are the potential side effects?
Potential side effects include those common to chemotherapy such as nausea, hair loss, increased risk of infection due to low blood cell counts; and from radiation therapy like fatigue and skin irritation. Long-term risks may involve cognitive impairment or growth development issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 6 and 10 years old with a creatinine level of 1 mg/dL or less.
Select...
My medulloblastoma is WNT type, confirmed by specific tests.
Select...
My cancer has a CTNNB1 mutation.
Select...
My medulloblastoma is of the WNT type, not the LC/A type.
Select...
My blood counts meet the required levels for neutrophils, platelets, and hemoglobin.
Select...
My kidney function is within the required range for my age and gender.
Select...
My bilirubin levels are normal and my liver enzyme (ALT) is below 135 U/L.
Select...
My cancer shows positive for beta-catenin.
Select...
My child is between 3 and 6 years old with a creatinine level of 0.8 mg/dL or less.
Select...
I am between 10 and 13 years old with a creatinine level of no more than 1.2 mg/dL.
Select...
My cancer does not have MYC or MYCN abnormalities.
Select...
My kidney function is normal or near normal.
Select...
I am 13-15 years old with a creatinine level below 1.5 (male) or 1.4 (female).
Select...
I am over 16 and my kidney function tests are within the normal range.
Select...
My bilirubin levels are within normal range for my age.
Select...
My tumor is less than 1.5 cm^2, confirmed by a special imaging review.
Select...
I am between 3 and 21 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
Body Weight Changes
Deoxyribonucleic acid (DNA) methylation profiling as real-time classification of WNT-driven medulloblastoma
Other outcome measures
Audiologic and endocrinologic toxicities
DNA methylation profiling of medulloblastoma real-time" predictive classification scheme for the SHH, group 3 and group 4 medulloblastoma subgroups according to the Heidelberg classifier
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (reduced radiation therapy and chemotherapy)Experimental Treatment8 Interventions
RADIATION THERAPY: Beginning 4-5 weeks after surgery, patients undergo craniospinal radiation therapy 5 days a week for 6 weeks.
MAINTENANCE THERAPY (WEEKS 1, 3, 5, and 7): Beginning 4-6 weeks after completion of radiation therapy patients receive lomustine PO on day 1, vincristine sulfate IV over 1 minute or via minibag on days 1, 8, and 15, and cisplatin IV over 6 hours on day 1. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY (WEEKS 2, 4, AND 6): Patients receive cyclophosphamide IV over 30-60 minutes on days 1 and 2, mesna IV over 15-30 minutes on days 1 and 2, and vincristine sulfate IV over 1 minute or via minibag on days 1 and 8. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients also undergo MRI throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Cisplatin
2013
Completed Phase 3
~1940
Cyclophosphamide
1995
Completed Phase 3
~3780
Vincristine
2003
Completed Phase 4
~2910
Lomustine
2008
Completed Phase 3
~1540
Vincristine Sulfate
2005
Completed Phase 3
~10110
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,108 Total Patients Enrolled
89 Trials studying Medulloblastoma
10,340 Patients Enrolled for Medulloblastoma
Children's Oncology GroupLead Sponsor
453 Previous Clinical Trials
237,655 Total Patients Enrolled
17 Trials studying Medulloblastoma
3,715 Patients Enrolled for Medulloblastoma
Nicholas J GottardoPrincipal InvestigatorChildren's Oncology Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (reduced radiation therapy and chemotherapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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)."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger