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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

No Placebo-Only Group

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:

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I haven't had any experimental treatments or chemotherapy within the last week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

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

Asthenia

Bronchitis

Nasopharyngitis

Alanine aminotransferase increased

Arthralgia

Headache

Neutropenia

Diarrhoea

Back pain

Hepatocellular injury

Transaminases increased

Insomnia

Abdominal pain

Urinary tract infection

Ear infection

Injection site erythema

Pruritus

Nausea

Hypertension

Gastric volvulus

Angioedema

Gastric ulcer

Intestinal ischaemia

Pulmonary embolism

Deep vein thrombosis

Hypertensive crisis

Iron deficiency anaemia

Cataract

Cervical dysplasia

Disseminated tuberculosis

Septic shock

Meningitis tuberculous

Fall

100%

80%

60%

40%

20%

Study treatment Arm

TCZ COMBO - All Participants

TCZ MONO - All Participants

TCZ - All Participants

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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