← Back to Search

Topoisomerase I inhibitors

Methotrexate + Etoposide for Recurrent Brain Cancer

Phase < 1
Recruiting
Led By David Sandberg, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis: Patients with histologically verified medulloblastoma, ependymoma, or atypical teratoid/rhabdoid tumor or other malignant brain tumor with recurrence or progression involving anywhere in the brain and/or spine. To be eligible, patients' disease must have originated in the posterior fossa of the brain
Patients must have recovered from the acute toxic effects of all prior anticancer chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights

Study Summary

This trial is testing whether it is safe to give two cancer drugs at the same time to people with brain tumors that have come back.

Who is the study for?
This trial is for children and adults aged 1-80 with recurrent malignant brain tumors in the posterior fossa, including medulloblastoma and ependymoma. Participants must have a life expectancy of at least 12 weeks, stable neurological deficits for a week before joining, adequate bone marrow function, an Ommaya reservoir or agree to have one placed, and not be on other treatment protocols.Check my eligibility
What is being tested?
The study tests the safety of infusing methotrexate and etoposide directly into the fourth ventricle or tumor cavity in the brain using an Ommaya reservoir. It targets patients whose cancer has returned after previous treatments. The aim is to see if this method can control tumor growth more effectively.See study design
What are the potential side effects?
Potential side effects may include reactions specific to chemotherapy such as nausea, vomiting, hair loss, mouth sores; local effects from infusion like headache or infection; decreased blood cells leading to increased infection risk; bleeding or anemia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer started in the back part of my brain and has come back or gotten worse.
Select...
I have recovered from side effects of my previous cancer treatments.
Select...
My blood tests show enough neutrophils, platelets, and hemoglobin.
Select...
I am mostly active and can do things for myself.
Select...
I had my last cancer treatment at least a week ago.
Select...
I am between 1 and 80 years old and my cancer has come back or gotten worse.
Select...
I have or agree to get a special device implanted for my brain tumor treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patients with grade 3 through grade 5 new neurological adverse events that are related to study drug, graded according to NCI CTCAE Version 4.0

Side effects data

From 2015 Phase 3 trial • 139 Patients • NCT02001987
14%
Rheumatoid arthritis
12%
Bronchitis
9%
Nasopharyngitis
9%
Rhinitis
7%
Asthenia
7%
Alanine aminotransferase increased
7%
Headache
6%
Back pain
6%
Ear infection
6%
Urinary tract infection
6%
Neutropenia
6%
Arthralgia
6%
Diarrhoea
5%
Injection site erythema
4%
Insomnia
4%
Pruritus
4%
Abdominal pain
4%
Nausea
4%
Transaminases increased
4%
Hypertension
4%
Hepatocellular injury
3%
Psoriasis
2%
Neck pain
1%
Deep vein thrombosis
1%
Cervical dysplasia
1%
Dyspepsia
1%
Gastric volvulus
1%
Intestinal ischaemia
1%
Vomiting
1%
Pulmonary embolism
1%
Hypertensive crisis
1%
Iron deficiency anaemia
1%
Myocardial infarction
1%
Cataract
1%
Angioedema
1%
Disseminated tuberculosis
1%
Septic shock
1%
Fall
1%
Nephrolithiasis
1%
Lung disorder
1%
Gastric ulcer
1%
Meningitis tuberculous
100%
80%
60%
40%
20%
0%
Study treatment Arm
TCZ - All Participants
TCZ COMBO - All Participants
TCZ MONO - All Participants

Trial Design

1Treatment groups
Experimental Treatment
Group I: Methotrexate / Etoposide InfusionExperimental Treatment3 Interventions
12 infusions of intraventricular Methotrexate and 15 infusions of intraventricular Etoposide into implanted fourth ventricle catheter/Ommaya reservoir following surgical catheter placement into fourth ventricle. Methotrexate will be infused twice weekly for 6 weeks and etoposide will be infused 5 times a week on weeks 1, 3 , and 5.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methotrexate
2013
Completed Phase 4
~3800
Etoposide
2010
Completed Phase 3
~2440
Ommaya Reservoir
2015
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
902 Previous Clinical Trials
320,894 Total Patients Enrolled
David Sandberg, MDPrincipal InvestigatorUTHealth
2 Previous Clinical Trials
407 Total Patients Enrolled

Media Library

Etoposide (Topoisomerase I inhibitors) Clinical Trial Eligibility Overview. Trial Name: NCT02905110 — Phase < 1
Brain Cancer Research Study Groups: Methotrexate / Etoposide Infusion
Brain Cancer Clinical Trial 2023: Etoposide Highlights & Side Effects. Trial Name: NCT02905110 — Phase < 1
Etoposide (Topoisomerase I inhibitors) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02905110 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals past the age of 55 eligible to participate in this experiment?

"All participants in this medical trial must meet the age requirement of at least 1 year old and not exceed 80 years."

Answered by AI

Is the recruitment phase of this experiment ongoing?

"Affirmative. According to the details hosted on clinicaltrials.gov, this medical trial is currently enlisting participants. It was initially published on October 1st 2016 and its most recent update occurred on August 17th 2022. There is a requirement for 10 patients at one site in particular."

Answered by AI

Which individuals have the criteria to participate in this experiment?

"This clinical trial is enlisting 10 individuals with recurrence, ranging in age from 1 year to 80. Necessary qualifications for enrolment include: A one week gap between the conclusion of systemic chemotherapy and/or radiation therapy and start of intracavitary treatment; a Lansky score or Karnofsky score of 50 or greater depending on their age; recovery from prior anticancer medications' adverse effects; an already-implanted catheter connected to an Ommaya reservoir (or agreement to get one installed); neurological stability over the past 7 days; life expectancy of at least three months as determined by the Principal Investigator (PI);"

Answered by AI

How many participants have been recruited into the experiment thus far?

"Affirmative. The clinicaltrials.gov website suggests that the trial is still in search of participants, having first been posted on October 1st 2016 and last modified on August 17th 2022. In total, 10 patients are needed to participate from a single medical site."

Answered by AI

Are there any additional investigations involving Methotrexate?

"Currently, there are 486 ongoing clinical trials examining the efficacy of Methotrexate. Of those studies, 135 have advanced to Phase 3 testing. Notably, while Seattle is a hub for research on this treatment, it is being researched in 19,513 locations worldwide."

Answered by AI

What conditions can Methotrexate typically be administered to address?

"Generally employed to treat bladder cancer, methotrexate can also be beneficial in managing conditions such as merkel cell carcinoma, meningeal leukemia and prostate cancer."

Answered by AI
~2 spots leftby Nov 2025