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Platinum-containing Compound
Chemotherapy + Radiation with/without Methotrexate for Brain Tumor
Phase 3
Waitlist Available
Research Sponsored by German Society for Pediatric Oncology and Hematology GPOH gGmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Newly diagnosed tumors of the brain or spinal cord meeting specified criteria
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying giving methotrexate with combination chemotherapy and radiation therapy to young patients with newly diagnosed gliomas to see if it is more effective than combination chemotherapy and radiation therapy alone.
Who is the study for?
This trial is for young patients with newly diagnosed high-grade brain or spinal cord tumors, including specific types like Glioblastoma and Anaplastic astrocytoma. Patients with a second cancer or spread-out metastases can join if radiation treatment area isn't too large. Those needing widespread craniospinal irradiation due to diffuse metastases cannot participate.Check my eligibility
What is being tested?
The study is testing the effectiveness of adding methotrexate to combination chemotherapy and radiation therapy versus just chemotherapy and radiation in treating gliomas. It's a phase III trial where patients are randomly assigned to either receive the additional drug or not.See study design
What are the potential side effects?
Chemotherapy drugs like etoposide, vincristine sulfate, ifosfamide, cisplatin, prednisone, lomustine may cause nausea, hair loss, mouth sores; methotrexate might add risks of liver damage and low blood cell counts. Radiation could lead to fatigue and skin changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My brain or spinal cord tumor is newly diagnosed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival (OS) rate at 5.5 years
Secondary outcome measures
Comparison of OS, progression-free survival, and event-free survival with historical control annually
Event-free survival
Health status
+3 moreSide effects data
From 2007 Phase 3 trial • 15 Patients • NCT020067067%
Infarctus myocardii
7%
Enterocolitis acuta
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rituximab/Methylprednisolone/MTX
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm IExperimental Treatment7 Interventions
Patients receive high-dose methotrexate IV over 24 hours on days 1 and 15 and leucovorin calcium IV every 6 hours on days 2-3 an 16-17. Four weeks later, patients undergo external beam radiotherapy once daily, 5 days a week, for approximately 6 weeks.
Beginning on the first day of radiotherapy, patients receive cisplatin IV over 1 hour on days 1-5, etoposide IV over 2 hours on days 1-3, and vincristine IV on days 5, 12, 19, 26, and 33. Beginning seven days prior to completion of radiotherapy, patients receive ifosfamide IV over 1 hour and cisplatin IV over 1 hour on days 1-5, etoposide IV over 2 hours on days 1-3, and vincristine IV on day 5.
Group II: Arm IIActive Control6 Interventions
Patients undergo external beam radiotherapy once daily, 5 days a week, for approximately 6 weeks.
Beginning on the first day of radiotherapy, patients receive cisplatin IV over 1 hour on days 1-5, etoposide IV over 2 hours on days 1-3, and vincristine IV on days 5, 12, 19, 26, and 33. Beginning seven days prior to completion of radiotherapy, patients receive ifosfamide IV over 1 hour and cisplatin IV over 1 hour on days 1-5, etoposide IV over 2 hours on days 1-3, and vincristine IV on day 5.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etoposide
FDA approved
Vincristine
FDA approved
Ifosfamide
FDA approved
Methotrexate
FDA approved
Cisplatin
FDA approved
Prednisone
FDA approved
Lomustine
FDA approved
Find a Location
Who is running the clinical trial?
German Society for Pediatric Oncology and Hematology GPOH gGmbHLead Sponsor
12 Previous Clinical Trials
9,964 Total Patients Enrolled
Gesellschaft fur Padiatrische Onkologie und Hamatologie - GermanyLead Sponsor
11 Previous Clinical Trials
9,907 Total Patients Enrolled
Christoph Kramm, MDStudy ChairUniversity Children's Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need full brain and spine radiation due to widespread cancer spread.My brain or spinal cord tumor is newly diagnosed.I have more than one tumor or cancer spread, but they can be targeted with radiation without covering a large area.I need medical help to breathe due to heart or lung problems.I need medication to manage my low blood pressure.I cannot move my limbs and I cannot communicate.I have had chemotherapy for a brain tumor.My health is in poor condition.My previous cancer treatment means I can't have more radiation.I do not have severe brain damage like being in a coma.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I
- Group 2: Arm II
Awards:
This trial has 4 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 30 Other Conditions - This treatment demonstrated efficacy for 30 other conditions.
- 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.
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.
Does this experiment have an age limit? If so, what is the maximum age of participants?
"Children who are at least 3 years old and not yet adults (18 years old) may participate in this trial."
Answered by AI
How many people are being asked to participate in this clinical trial?
"This particular clinical trial is not open for recruitment at this moment in time. The first posting was on September 1st, 2003 with the most recent update being December 18th, 2013. However, there are 444 other trials searching for patients with glioma and 1421 trials involving methotrexate that are currently enrolling patients."
Answered by AI
What are some of the most common indications for methotrexate?
"Methotrexate is a medication that has been used to treat ophthalmia, sympathetic. Other potential uses for this drug include the treatment of prostate cancer, advanced testicular cancer, and small cell lung cancer (sclc)."
Answered by AI
Are people with the necessary qualifications able to participate in this clinical trial right now?
"Searching for other studies 444 trials actively looking for participants with glioma and 1421 studies for methotrexate actively enrolling participants."
Answered by AI
How do I sign up for this research project?
"This particular clinical study is testing an investigational medication for glioma in children aged 3-18. They are enrolling a total of 150 people in this trial."
Answered by AI
Has methotrexate been cleared for use by the FDA?
"There is prior clinical data supporting methotrexate's safety, so it received a score of 3."
Answered by AI
Can you tell us about other research studies that have used methotrexate?
"At the moment, there are 1,421 clinical trials investigating methotrexate. 465 of those live trials are in Phase 3 testing. The majority of trials for methotrexate are based in Houston, Texas; however, there are 69,937 locations running studies for this treatment globally."
Answered by AI
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