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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
Must not have
Has received another investigational or chemotherapy agent or radiation therapy within 7 days prior to intraventricular chemotherapy infusions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I haven't had any experimental treatments or chemotherapy within the last week.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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
11%
Rheumatoid arthritis
11%
Rhinitis
9%
Asthenia
9%
Bronchitis
8%
Nasopharyngitis
8%
Alanine aminotransferase increased
8%
Arthralgia
8%
Headache
7%
Neutropenia
6%
Diarrhoea
5%
Back pain
5%
Hepatocellular injury
5%
Transaminases increased
5%
Insomnia
5%
Abdominal pain
4%
Urinary tract infection
3%
Ear infection
3%
Injection site erythema
3%
Pruritus
2%
Nausea
2%
Hypertension
1%
Gastric volvulus
1%
Angioedema
1%
Gastric ulcer
1%
Intestinal ischaemia
1%
Pulmonary embolism
1%
Deep vein thrombosis
1%
Hypertensive crisis
1%
Iron deficiency anaemia
1%
Cataract
1%
Cervical dysplasia
1%
Disseminated tuberculosis
1%
Septic shock
1%
Meningitis tuberculous
1%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
TCZ COMBO - All Participants
TCZ MONO - All Participants
TCZ - 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
2019
Completed Phase 4
~4400
Etoposide
2010
Completed Phase 3
~2960
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
934 Previous Clinical Trials
333,798 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
~1 spots leftby Nov 2025
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