Your session is about to expire
← Back to Search
APX005M for Pediatric Brain Cancer
Study Summary
This trial studies the side effects and best dose of APX005M in treating younger patients with primary malignant central nervous system 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
Find a Location
Who is running the clinical trial?
Media Library
- I have a newly diagnosed brainstem tumor without needing a biopsy.I have had a severe allergic reaction to a monoclonal antibody treatment.My cancer in the central nervous system is returning, worsening, or not responding to treatment.I have recovered from side effects of my previous cancer treatments.My neurological symptoms have been stable for at least a week.I do not have any serious illnesses or infections that could affect my participation.I've been cancer-free for 5 years, except for a secondary brain tumor.I have a bleeding disorder or need blood-thinning medication.It's been over 6 months since my stem cell transplant and my CD4 count is above 200.I am between 1 and 21 years old.I received my last cancer treatment affecting my bone marrow 21 days ago, or 42 days ago if it was a specific type called nitrosourea.I have an autoimmune disease that needs ongoing treatment with steroids or immunosuppressants.I am not currently on any cancer treatment or experimental drugs.I have received a stem cell transplant from a donor.I am a woman who can have children and have a negative pregnancy test.My organs and bone marrow are functioning well.I am not pregnant or breast-feeding.I had significant radiation therapy more than 3 months ago.I am of any gender and ethnicity.I can care for myself but may need occasional help.You have a large tumor seen on imaging.I will use birth control or abstain from sex while on APX005M and for 30 days after.I had major surgery over 4 weeks ago and have recovered from it.I've recovered from side effects of my last biological treatment, which was over a week ago.Enough time has passed since my last monoclonal antibody treatment.
- Group 1: Stratum 1
- Group 2: Stratum 2
- 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
Are there any dangers in using APX005M to treat cancer patients whose tumors have not responded to other treatments?
"While there is some data suggesting efficacy, APX005M's safety is mostly unknown due to the fact that this is only a Phase 1 trial. As such, it received a score of 1."
Are there other drugs like APX005M that have been tested on people with brain cancer that keeps coming back or doesn't respond to treatment?
"MD Anderson Cancer Center conducted the first study of APX005M in 2017 as a treatment for patients with recurrent or refractory primary malignant CNS tumors. To date, 3 such trials have been completed with 8 more active studies. A large portion of these studies are based out of Atlanta, Georgia."
Are people who are over 20 welcome to participate in this research project?
"According to the eligibility requirements, patients that fall between 1 year old to 21 years old can apply to be in this clinical trial. Out of the 834 similar studies, this is one of the 209 studies that focus on a pediatric population and one of the 625 studies for people over the age of 65."
What are the goals that this team of researchers is hoping to achieve?
"The primary outcome of this 2-year study will be to understand the pharmacokinetics of APX005M. Additionally, researchers will also be evaluating the duration of response, overall survival for DIPG patients, and progression-free survival."
Is this clinical trial novel in design or execution?
"Since 2017, APX005M treatment for recurrent or refractory primary malignant CNS tumor patients has been studied by medical researchers. The first study, which had 41 participants, was conducted in 2017 and sponsored by Apexigen, Inc. After the successful first study, APX005M received Phase 1 & 2 drug approval. Currently, there are 8 active studies being conducted in 22 cities and 3 countries."
Can people with the required qualifications sign up for this research project at the present time?
"Yes, this is an active recruitment trial that was originally posted on February 2nd, 2018. The study is looking for 45 patients to enroll from 11 different sites."
Who meets the standard to participate in this research?
"This study is looking for 45 patients, within the ages of 1 and 21, who have medulloblastoma. It is required that participants also meet the following criteria:-Diagnosis: Recurrent or refractory primary malignant CNS tumor patients must have a histologically confirmed diagnosis of a primary malignant non-brainstem CNS tumor (excluding DIPG patients) that is recurrent, progressive, or refractory. All tumors must have histologic verification at either the time of diagnosis or recurrence, except patients with marker (+) CNS germ cell tumors.-Available Pre-trial"
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger