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Combination Therapy for Brain Cancer
Study Summary
This trial will help improve cure rates for children with brain tumors by studying how the tumors continue to resist modern advances and by testing new approaches to treatment.
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?
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- My brain tumor is growing or returning despite treatment.I have not taken smoothened inhibitors in the last 6 months.I have a history of serious heart disease that is not under control.You have a history of prolonged QTc interval (more than 450 milliseconds).You have other important health issues that could make it hard for you to handle the treatment or affect the study results.Your heart's pumping ability is significantly lower than normal.My tumor is a specific type of brain cancer that has not responded to treatment.I am between 1 and 24 years old.I am not pregnant, can take a pregnancy test, and will use effective birth control during and after the study.My bones have fully developed according to my age.I am a man who can father children and agree to use contraception during and for 8 months after treatment.I have been on a stable or decreasing dose of corticosteroids for at least 1 week.I can do some activities and am expected to live at least 6 more weeks.My cancer can be measured or seen on scans.I received my last cancer treatment over 4 weeks ago.I finished my last radiation session at least 4 weeks ago, or 2 weeks ago if it was for symptom relief.I am not currently taking medications that strongly affect liver enzymes or that can alter my heart rhythm.I am not pregnant, can take a pregnancy test, and will use effective birth control during and 8 months after the study.I have been treated with a CDK4/6 inhibitor before.I am currently breastfeeding.I have been diagnosed with subependymoma or myxopapillary ependymoma.I have been diagnosed with Low Grade Glioma or Diffuse Intrinsic Pontine Glioma.I can swallow pills or have a g-tube for medication.My medulloblastoma is worsening or not responding to treatment, and my tumor has specific genetic changes.I have been treated with a MEK inhibitor before.I have been treated with a MEK inhibitor before.I can swallow pills.My weight and body surface area meet the trial's requirements.I am between 10 and 40 years old.Your heart's electrical activity (measured by ECG) shows a prolonged QTc interval (> 450 msec).I am between 1 and 24 years old, or up to 39 years old with specific brain cancer.I have a confirmed RB1 gene mutation.I have been diagnosed with retinal vein occlusion.I am a man willing to use contraception during and for 16 weeks after treatment.I am between 1 and 24 years old.My condition is a recurring or worsening low grade brain tumor.I can understand and am willing to sign the consent form.My brain tumor is growing or has come back despite treatment.My bone marrow and organs are functioning well.I have stopped taking any herbal or dietary supplements, except multivitamins, 7 days before joining the study.
- Group 1: A: ribociclib + gemcitabine
- Group 2: B: ribociclib + trametinib
- Group 3: C: ribociclib + sonidegib
- 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
How many persons have enrolled in this clinical inquiry?
"Yes, the data on clinicaltrials.gov shows that this medical study is currently in search of participants. This trial initially went live on March 5th 2018 and was last revised on April 1st 2022. There are 108 spots open across a single site for participation."
What has ribociclib been demonstrated to be efficacious for?
"Primarily used to combat infection, ribociclib can also be employed for urinary bladder issues, stem cell mobilization therapy and small-cell lung cancer treatment."
Are there any remaining slots available in this clinical trial?
"Clinicaltrials.gov demonstrates that this trial is still in search of patients; it was first published on the 5th March 2018 and last amended on 1st April 2022."
What prior research has been conducted surrounding ribociclib's efficacy?
"At the moment, 737 clinical trials are being conducted for ribociclib. Of those active studies, 182 have been elevated to Phase 3. Most of these tests are located in Adelaide South Australia; however there is a total 36108 trial sites across the globe involved with this medication."
Is it possible to join this clinical investigation?
"The eligibility requirements of this clinical trial necessitate candidates with ependymoma and aged between 1 year old to 39 years. A total of 108 patients must be recruited in order for the study's goals to be achieved."
Is the usage of ribociclib associated with any known adverse effects?
"Whilst there is some evidence of efficacy, due to the trial being in Phase 1, limited data exists for ribociclib's safety. As a result our assessment rated it at level 1 on the scale from 1 to 3."
Does this research encompass participants below the age of 20?
"To qualify for this clinical trial, the patient must fall between 1 Year and 39 Years of age. Additionally, 841 studies are available for those under 18 years old and 4485 exist for seniors above 65."
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