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Cytokine
GM-CSF for Ependymoma
Phase < 1
Waitlist Available
Led By Nicholas Foreman, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Organ Function Requirements:
--- 6 to < 10 years 1 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 years
Awards & highlights
Study Summary
This trial will study whether GM-CSF can improve outcomes for patients with ependymoma by increasing infiltration of immune cells.
Who is the study for?
This trial is for young people (age >12 months and <21 years) with a specific brain tumor called posterior fossa ependymoma. They must have had only partial removal of the tumor in surgery, no spread beyond the primary site, good kidney and liver function, and acceptable blood counts. It's not for those with other types of ependymomas or tumors that have spread.Check my eligibility
What is being tested?
The study tests Granulocyte Macrophage Colony Stimulation Factor (GM-CSF) on patients with ependymoma to see if it helps immune cells fight the tumor better. The focus is on whether GM-CSF can improve patient outcomes by boosting their immune response against the cancer.See study design
What are the potential side effects?
While specific side effects are not listed here, GM-CSF may generally cause reactions at injection sites, bone pain, fatigue, fever-like symptoms, and sometimes affect blood pressure or cause flu-like symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My organs are functioning well.
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I am between 6 and 9 years old.
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I am mostly able to care for myself and carry out daily activities.
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My bone marrow is working well.
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My brain scans show cancer hasn't spread beyond its original location.
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My bilirubin levels are within the normal range for my age.
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My diagnosis is ependymoma, confirmed through tissue examination.
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I was recently diagnosed with a specific brain tumor and didn't have all of it removed during my first surgery.
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My MRI shows my spine cancer hasn't spread beyond the main area.
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I am between 1 and 20 years old.
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I am able to care for myself and perform daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with increased M/M infiltration compared to institutional and ACNS0121 controls
Trial Design
2Treatment groups
Experimental Treatment
Group I: GM-CSF treatment at second-look surgery armExperimental Treatment1 Intervention
Newly diagnosed patients with EPN who have a subtotal resection at initial presentation and are without evidence of metastatic tumor will be enrolled in this stratum. Total patient population in this stratum will be 10 patients. It should be noted that prior experience suggests that about 1/3 of newly presenting patients still have residual tumor after the initial surgery
Group II: GM-CSF treatment at recurrence arm.Experimental Treatment1 Intervention
EPN patients with a first regional relapse and without evidence of metastatic tumor will be enrolled in this stratum. Total patient population will be 10 patients.
Patients with a first recurrence will have the recurrence confirmed by the local institutional neuro-radiologists. They will have the entire neuro-axis scanned and a spinal tap performed (where safe) to exclude metastatic tumor. They will then receive 5 days of GM-CSF and then proceed to surgery if deemed clinically indicated by the treating physician
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Granulocyte Macrophage Colony Stimulation Factor
2013
Completed Early Phase 1
~10
Find a Location
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,731 Previous Clinical Trials
2,144,591 Total Patients Enrolled
1 Trials studying Ependymoma
33 Patients Enrolled for Ependymoma
National Cancer Institute (NCI)NIH
13,648 Previous Clinical Trials
40,931,734 Total Patients Enrolled
81 Trials studying Ependymoma
8,918 Patients Enrolled for Ependymoma
Children's Hospital ColoradoOTHER
115 Previous Clinical Trials
5,127,609 Total Patients Enrolled
1 Trials studying Ependymoma
33 Patients Enrolled for Ependymoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is normal.My organs are functioning well.I am between 6 and 9 years old.My kidney function, measured by creatinine levels, is within the normal range for my age and gender.I am mostly able to care for myself and carry out daily activities.My child is between 2 and less than 6 years old.I have Gilbert syndrome or hemolytic anemia, but my total bilirubin is less than 3 times the normal upper limit.My bone marrow is working well.I am between 13 and less than 16 years old.I am 16 years old or older.I am between 10 and less than 13 years old.My brain scans show cancer hasn't spread beyond its original location.My bilirubin levels are within the normal range for my age.My diagnosis is ependymoma, confirmed through tissue examination.My cancer is not any type of ependymoma or mixed glioma.I was recently diagnosed with a specific brain tumor and didn't have all of it removed during my first surgery.My MRI shows my spine cancer hasn't spread beyond the main area.My liver is working well.I am between 1 and 20 years old.I am able to care for myself and perform daily activities.My kidney function, based on my age and gender, is within the required range.My condition has been present for 1 to less than 2 years.My ependymoma has returned for the first time in the posterior fossa area.
Research Study Groups:
This trial has the following groups:- Group 1: GM-CSF treatment at second-look surgery arm
- Group 2: GM-CSF treatment at recurrence arm.
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.
Are there current opportunities for volunteers to join this experiment?
"According to clinicaltrials.gov, this medical research is no longer accepting volunteers for the study which opened on June 25th 2013 and was last edited February 8th 2022. Nonetheless, there are still 52 different trials actively recruiting individuals at this time."
Answered by AI
Is the minimum participation age for this experiment 18 years or older?
"This clinical trial aims to enrol patients aged between one year old and 21. There are 47 trials specifically designed for those younger than 18, while 10 of these studies focus on individuals above the age of 65."
Answered by AI
Who meets the criteria for enrolling in this medical experiment?
"This clinical trial is seeking 6 individuals under 21 years of age, suffering from ependymoma. The key requirements for enrolment include being newly diagnosed with posterior fossa ependymoma after a partial resection surgery (stratum 1), or in the first relapse stage of their condition (stratum 2). Additionally, eligible candidates must have an Eastern Cooperative Oncology Group performance score of 0-2 and not be contraindicated to lumbar CSF examination."
Answered by AI
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