Methotrexate for Brain Cancer

Phase-Based Estimates
1
Effectiveness
1
Safety
UTHealth & Children's Memorial Hermann Hospital, Houston, TX
Brain Cancer+2 More
Methotrexate - Drug
Eligibility
Any Age
All Sexes
Eligible conditions
Brain Cancer

Study Summary

This study is evaluating whether a combination of chemotherapy drugs may be effective for treating recurrent brain tumors.

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Eligible Conditions

  • Brain Cancer
  • Brain Neoplasms
  • Relapse
  • Recurrence
  • Recurrent Brain Tumors

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Methotrexate will improve 1 primary outcome in patients with Brain Cancer. Measurement will happen over the course of 4 months.

4 months
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

Trial Safety

Trial Design

2 Treatment Groups

Control
Methotrexate / Etoposide Infusion

This trial requires 10 total participants across 2 different treatment groups

This trial involves 2 different treatments. Methotrexate is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Methotrexate / Etoposide Infusion12 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.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methotrexate
FDA approved
Etoposide
FDA approved
Ommaya Reservoir
2015
Completed Phase 1
~20

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 4 months for reporting.

Who is running the study

Principal Investigator
D. I. S.
Prof. David Ilan Sandberg, Director of Pediatric Neurosurgery, Associate Professor Pediatric Surgery and Neurosurgery
The University of Texas Health Science Center, Houston

Closest Location

UTHealth & Children's Memorial Hermann Hospital - Houston, TX

Eligibility Criteria

This trial is for patients born any sex of any age. You must have received 1 prior treatment for Brain Cancer or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients with a histologically verified malignant brain tumor that has recurred or progressed, and involves any part of the brain or spine, are eligible for this study. show original
A minimum of 7 days must elapse between the last dose of systemic chemotherapy and/or radiation therapy and the first infusion of chemotherapy into the fourth ventricle. show original
If the person is ≤16 years of age, their Lansky score must be 50 or greater or their Karnofsky score must be 50 or greater if they are >16 years of age. show original
before initiation of BR Patients must have fully recovered from any and all toxic effects of their prior cancer treatments before starting treatment with bevacizumab. show original
A catheter that is implanted in the fourth ventricle or tumor cavity in the posterior fossa and is attached to an Ommaya reservoir or has been agreed to have one placed. show original
To be eligible for this study, you must have neurological deficits that have been stable for at least 1 week. show original
The person has adequate bone marrow function if their peripheral absolute neutrophil count is at least 500/µL, their platelet count is at least 50,000/µL (transfusion independent), and their hemoglobin is at least 9.0 gm/dL show original
The patient must have a tumor that can be measured or evaluated using an MRI of the brain and total spine. show original
The PI believes that life expectancy is at least 12 weeks. show original
The person is between 1 and 80 years old at the time of the recurrence or progression of the disease. show original

Patient Q&A Section

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

Can brain cancer be cured?

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The standard treatment procedures for brain tumors do not seem to provide a complete cure for the brain tumor. Although metastatic brain tumors can be responsive to chemotherapy, complete surgical resection is necessary to obtain long-term disease-free survival in all types of brain cancer. There is no evidence that any of the forms of brain tumor therapy can cure the disease (including surgical resection).

Unverified Answer

What causes brain cancer?

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There is no single cause at the molecular level of brain cancer. The most widely accepted view is that brain cancer develops from an accumulation of genetic mistakes resulting in uncontrolled cell growth in the brain or brain tissues. A variety of factors may be involved in the development of these genetic defects, including genetics, viral infections, exposure to chemical and physical agents, dietary factors, or chemical and occupational exposures. Some specific types of brain cancer may have an identifiable risk factor. The most well-known factors so far identified by research are tobacco smoking and alcohol consumption, but most other risk factors, such as diabetes and obesity, are still being studied and need more attention. In addition to these factors, there are some environmental agents that predispose individuals to developing brain tumors.

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How many people get brain cancer a year in the United States?

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Although not all patients with [brain tumor](https://www.withpower.com/clinical-trials/brain-tumor)s will develop secondary brain metastases, these patients are at substantial risk of this catastrophic sequelae. With an average diagnosis in situ interval of 12.3 months for glioblastoma multiforme patients, this high risk has significant ramifications for clinical management.

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What are the signs of brain cancer?

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Itchiness, feeling irritable and trouble sleeping are common symptoms of a brain tumor. Seizures are the most common symptom in children under 10. If a child complains of vomiting or a loss of consciousness, a brain tumor should be suspected. Seizures may be an indicator of brain cancer, particularly if associated with focal neurological problems. Seizures are likely to be epilepsy, which may be an indicator of brain cancer. Seizures also may be brought on by certain drugs, such as amphetamines, cocaine and barbiturates.

Unverified Answer

What are common treatments for brain cancer?

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The average number of treatment sessions per patient ranged from 1.2 to 8.8 for the four treatments. A substantial number of patients underwent no treatment, but the average time in treatment was 0.76 months for non-Surgical patients and 0.56 months for Surgicals.

Unverified Answer

What is brain cancer?

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Brain tumour can be summarized in two main categories: glioma and neuroblastoma. Neuroblastoma is the most common form and typically is found at lower stage. In most cases, it is benign but it can behave as a low-grade or high-grade tumour. Gliomas are the most common type of intracranial cancer and can arise from either the non-enhantown, non-central nervous system tumours. Many types of gliomas have been identified. Prognosis depends on factors such as stage, type and location. Brain cancer can arise from any part of the CNS.

Unverified Answer

How does methotrexate work?

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Low doses do not kill brain tumor cells. Tumor cells survive because the cells are 'protected' from the drugs and tumor cells do not die because they are out-competed by normal cells. Methotrexate may not do this and causes a dose-limiting side-effect that may kill off healthy cells that would ordinarily be killed off by the drug. So the 'therapy is more effective than the disease' for as little as 50 minutes a day.

Unverified Answer

What does methotrexate usually treat?

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Methotrexate is a medication that can be used as an alternative in some cases. There must be careful choice of the dosage that is given.\n

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Have there been other clinical trials involving methotrexate?

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A more thorough search would enable to identify four additional randomised trials of MTX for treatment of brain tumours published in the 1980s and 1990s with the same end-points as the present case paper. There may be several other methotrexate brain tumour studies published in the last two decades. None of these are randomised trials and none are published in the leading medical journals.

Unverified Answer

Is methotrexate safe for people?

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Results from a recent paper provide further evidence regarding the safety of methotrexate. A dosage regimen of at least 1 g/m has been found to be well tolerated.

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What is the primary cause of brain cancer?

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There is still debate about whether mobile phone exposure plays a significant role in oncogenesis. It is also difficult to rule out other major biological effects of short-term mobile phone use in the human body. We also lack adequate knowledge about the primary molecular mechanisms of tumour promotion by wireless exposure. Future research is necessary to identify the main causes of brain tumours, and also to establish mechanisms of action leading from cellular alterations and genetic changes to oncogenesis.

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Does brain cancer run in families?

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Results from a recent paper suggest that [brain cancer](https://www.withpower.com/clinical-trials/brain-cancer) families are significantly more likely to have a family member who suffers from this disease. Although the effect size of these associations was relatively modest, it is the first study of its kind to link cancer susceptibility to brain cancer risk in an affected family member.

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