methotrexate for Glioma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Glioma+3 More
methotrexate - Drug
Eligibility
< 65
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Glioma
  • Brain and Central Nervous System Tumors

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 6 Secondary · Reporting Duration:

Comparison of OS, progression-free survival, and event-free survival with historical control annually
Event-free survival
Health status
Long-term sequelae annually
Overall survival (OS) rate at 5.5 years
Progression-free survival
Tumor response

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Rituximab/Methylprednisolone/MTX
7%Enterocolitis acuta
7%Infarctus myocardii
This histogram enumerates side effects from a completed 2007 Phase 3 trial (NCT02006706) in the Rituximab/Methylprednisolone/MTX ARM group. Side effects include: Enterocolitis acuta with 7%, Infarctus myocardii with 7%.

Trial Design

2 Treatment Groups

Arm II
1 of 2
Arm I
1 of 2
Active Control
Experimental Treatment

150 Total Participants · 2 Treatment Groups

Primary Treatment: methotrexate · No Placebo Group · Phase 3

Arm IExperimental Group · 7 Interventions: etoposide, cisplatin, vincristine sulfate, ifosfamide, methotrexate, prednisone, lomustine · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug, Drug
Arm IIActiveComparator Group · 6 Interventions: etoposide, cisplatin, vincristine sulfate, ifosfamide, prednisone, lomustine · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etoposide
FDA approved
Cisplatin
FDA approved
Vincristine
FDA approved
Ifosfamide
FDA approved
Methotrexate
FDA approved
Prednisone
FDA approved
Lomustine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

Gesellschaft fur Padiatrische Onkologie und Hamatologie - GermanyLead Sponsor
11 Previous Clinical Trials
9,907 Total Patients Enrolled
Christoph Kramm, MDStudy ChairUniversity Children's Hospital

Eligibility Criteria

Age < 65 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Atypical oligoastrocytoma of the brainstem.
You have a primary brain tumour (WHOº IV).
You have a tumor that is a grade III astrocytoma.
You have no cardiorespiratory insufficiency requiring medical respiration.
You have no severe neurological damage.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 26th, 2021

Last Reviewed: October 29th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.