Your session is about to expire
← Back to Search
Selumetinib + Vinblastine for Low-Grade Glioma
Study Summary
This trial is investigating whether adding vinblastine to selumetinib improves treatment of recurrent or progressive low-grade glioma in children and young adults.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 2 trial • 8 Patients • NCT03040986Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- You must be between 2 and 21 years old to participate in the study's feasibility phase.You are allergic to selumetinib, vinblastine, or similar drugs.You have existing eye problems.You have glaucoma that is not being managed or controlled.You have had treatment for any other type of cancer within the last year, besides surgery.You cannot have stopped taking vinblastine or selumetinib because of negative side effects.You must be able to swallow capsules without crushing or breaking them.You have a tumor that can be measured and its size is at least 1 square centimeter.If you have a history of seizures, you should not have had more seizures than usual in the 2 weeks leading up to the study.You have a heart condition before participating in the trial.You have symptoms of heart failure.You have a serious problem with one of your heart valves.You cannot be taking any other experimental drugs.You have a past record of irregular heartbeat called atrial fibrillation.You are a breastfeeding mother who plans to continue breastfeeding during the study.You currently have an infection that is not under control.You can participate in the trial if you have either cancer that has spread to other parts of the body or multiple brain tumors that are not related to each other.You must have a certain body size, with a surface area of at least 0.5 square meters.You must be between 2 and 25 years old when you join the study.The size of the tumor will be measured, including both solid and fluid-filled parts, as well as a specific type of MRI signal.The type of brain tumor you have is considered low-grade (not very aggressive) according to the World Health Organization's classification system. However, if you have a type called subependymal giant cell astrocytoma, you won't be eligible.
- Group 1: Efficacy Phase Arm II (selumetinib)
- Group 2: Feasibility & Efficacy Phase Arm I (selumetinib, vinblastine)
- 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
What is the primary indication for Selumetinib Sulfate?
"Selumetinib Sulfate is an effective treatment for advanced testicular cancer, lymphoma, hodgkins disease, and breast cancer."
Is this clinical trial being run in numerous locations throughout the state?
"There are 67 sites running this trial, including Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center in Houston, University of Illinois in Chicago, Cardinal Glennon Children's Medical Center in Saint Louis, and other locations."
Who would be an ideal candidate for this clinical test?
"Researchers are looking for 300 individuals, falling in the 2-25 year old age bracket, that have glioma. In addition to this broad criteria, patients must also meet the following more specific requirements: Efficacy phase: at enrollment, patients must be between 2 and 25 years old, must have a body surface area of at least 0.5 m^2 , have a two-dimensional measurable tumor volume of 1 cm^2 or greater, with tumor size including both solid and cystic components of the tumor (whether or not tumor is enhancing) + fluid attenuated inversion recovery (FLAIR) signal. Eligible hist"
Are there comparable clinical trials that have used Selumetinib Sulfate?
"Selumetinib Sulfate was first studied in the year 2002 at Canberra Hospital. So far there have been 475 completed trials. There are currently 138 actively recruiting trials, with many of these trials being performed out of Houston, Texas."
How many test subjects are in this experiment?
"Yes, the clinical trial is still recruiting patients. The details were last updated on November 9th, 2022 and it was originally posted on January 8th, 2021. They are looking for 300 total patients from 67 different hospitals or clinics."
Can young adults participate in this research?
"To be eligible for this particular trial, applicants must fall between the ages of 2 and 25. Out of all the ongoing trials, 331 are for patients below 18 years old while 1244 are for senior citizens aged 65 and above."
Are we still recruiting patients for this research project?
"That is correct. The latest information on clinicaltrials.gov shows that this trial is still looking for patients. It was first posted over a year ago on 8/1/2021 and was most recently updated on 9/11/2022. There are 67 hospitals or clinics participating in the study, and they are hoping to enroll 300 people total."
What is the current FDA status of Selumetinib Sulfate?
"Selumetinib Sulfate Phase 3 trials have yielded some efficacy data, and there are numerous rounds of safety data, so it receives a score of 3."
What hypotheses is this research trying to confirm?
"The primary goal of this clinical trial is to Event-free survival (efficacy), which will be measured over a 1 month post enrollment time frame. Secondary outcomes include Radiographic tumor response rate (efficacy) and Visual outcome comparison, which will be assessed using an exact binomial test to compare the difference in the proportion of subjects in each arm that show improvement in visual acuity per Teller Acuity assessment after 12 months of treatment. Additionally, EFS by BRAF Status will be estimated using KM methods to estimate the difference in EFS and between patients with BRAF rearranged LGG and patients with non-B"
Who else is applying?
What state do they live in?
How old are they?
What portion of applicants met pre-screening criteria?
What site did they apply to?
Share this study with friends
Copy Link
Messenger