CLINICAL TRIAL

methotrexate for Glioma

Waitlist Available · < 65 · All Sexes · Houston, TX

This study is evaluating whether giving methotrexate together with combination chemotherapy and radiation therapy is more effective than combination chemotherapy and radiation therapy alone in treating young patients with newly diagnosed gliomas.

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About the trial for Glioma

Eligible Conditions
Glioma · Nervous System Neoplasms · Brain and Central Nervous System Tumors · Central Nervous System Neoplasms

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 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
cisplatin
DRUG
etoposide
DRUG
methotrexate
DRUG
ifosfamide
DRUG
lomustine
DRUG
vincristine sulfate
DRUG
prednisone
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
cisplatin
DRUG
etoposide
DRUG
ifosfamide
DRUG
lomustine
DRUG
vincristine sulfate
DRUG
prednisone
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
FDA approved
Etoposide
FDA approved
Methotrexate
FDA approved
Ifosfamide
FDA approved
Lomustine
FDA approved
Vincristine
FDA approved
Prednisone
FDA approved

Eligibility

This trial is for patients born any sex aged 65 and younger. You must have received newly diagnosed for Glioma or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Gliosarcoma (WHOº III or IV)
Anaplastic oligo-astrocytoma NOTE: *Histological requirement may be waived for other types of brainstem glioma
Second malignancy or disseminate metastases or multifocal tumors are allowed if the field of irradiation is not too large
No diffuse metastases making craniospinal irradiation necessary
No cardiorespiratory insufficiency requiring medical respiration
No low blood pressure requiring systemic catecholamines
No severe neurological damage (e.g., coma)
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 5 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether methotrexate will improve 1 primary outcome and 6 secondary outcomes in patients with Glioma. Measurement will happen over the course of .

Health status
Event-free survival
Comparison of OS, progression-free survival, and event-free survival with historical control annually
Progression-free survival
Long-term sequelae annually
Tumor response
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Patient Q & A Section

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

What are the signs of glioma?

Sudden hearing loss, difficulty swallowing or eating, weakness in one or both limbs and sudden weakness in both limbs are some common symptoms of glioma. Other common symptoms vary, depending on the stage of the tumor.

Anonymous Patient Answer

How many people get glioma a year in the United States?

About 25,000 cases of glioma are diagnosed each year in the United States. The incidence of glioma is higher in African Americans than in Caucasians. Younger age of onset is seen among people of black African descent. These data suggest that there is a higher incidence of childhood glioma among Asian and African Americans compared with Caucasians across the United States.

Anonymous Patient Answer

What are common treatments for glioma?

Most glioma patients are treated with chemotherapy, and some receive radiotherapy. There is no evidence of a survival benefit after surgery. The effect of surgery on longer-term survival is unclear. Better quality evidence is required to inform guidelines for glioma treatment.

Anonymous Patient Answer

What causes glioma?

The cause of all forms of brain tumour is an unsolved problem but there are a couple of hypotheses which explain some aspects of the disease pathogenesis. Genetic factors may determine susceptibility to glioma, although how they are regulated remains unclear. Gliomas may develop when the tumour suppresses the body's immune system. The most common tumours seen in patients with HPA-secreting adenomas and pituitary insufficiency (PROPIT, HyperPRED, and PROMIS) occur in a similar way and so they may be due to abnormal activation of the hypothalamic-pituitary-adrenal axis or the GH-IGF1 axis.

Anonymous Patient Answer

What is glioma?

Nearly all gliomas arise from the surface of the brain and spinal cord. At initial presentation, children may often have mild neurological deficits due to intracerebral mass effect. A significant percentage of children have recurrent seizures. Children with malignant gliomas often present with abnormal growth or loss of sensory or motor function. The primary prognostic determinants of survival in malignant gliomas are age, extent of disease at initial presentation, and tumor grade. Glioma of all types is a rare cancer, with an annual incidence rate in children of between 0.5 and 10 persons per 100 000. Of these, approximately one quarter of all cases have a pediatric onset. Males have a slightly higher incidence than females.

Anonymous Patient Answer

Can glioma be cured?

There has been no statistically significant (p= 0.26) improvement in patient survival from time to the beginning of treatment over the last decade. Survival can be improved by the resection of the primary tumors in high grade tumors in some patients. In others, resection was not successful. The development of more chemotherapeutic modalities in the therapy of malignant high grade gliomas should be encouraged in this situation.

Anonymous Patient Answer

Have there been any new discoveries for treating glioma?

It is recommended that MRI be routinely used in the diagnosis of glioma. Patients with Grade 2 tumors, those with no evidence of tumor extension into the ventricles, and those who do not have focal cortical enhancement, are most likely to have malignant progression (Grade 3). It is unlikely that a high-risk patient with grade 1 or 2 glioma would be treated by resection alone because of the high rate of recurrence at this particular grade.

Anonymous Patient Answer

Who should consider clinical trials for glioma?

Considerable methodological shortcomings limit the usefulness of retrospective and national, and local, data for estimating effectiveness of treatment options. Prospective trials that compare surgical resection plus adjuvant radiotherapy with surgery plus radiotherapy are feasible and required to determine definitive treatment options and to test efficacies of therapies that have been applied in the past. Clinical trials should include a significant proportion of patients with WHO 2/3. WHO grade III is contraindicated because it makes it more difficult to conduct a clinical trial and to interpret results.

Anonymous Patient Answer

How does methotrexate work?

Given the fact that the tumor cells are highly dependent on uracil as uracil can only be obtained from dietary sources, methotrexate may be able to alter purine metabolism and thereby induce a buildup in cytosolic levels of uracil, which is known to selectively induce G2/M arrest by a mechanism very different from that of the nucleoside analogs 5-FU and 8-oxoguanine. It is proposed that this effect may be used when methotrexate is used by itself as compared to the DNA damaging effects of 5-FU and 8-oxoguanine, because it increases the risk of toxicity.

Anonymous Patient Answer

What does methotrexate usually treat?

This medication is also used as an antineoplastic on other tumors and for other disease. It is most effective in [brain tumor](https://www.withpower.com/clinical-trials/brain-tumor)s. It is a medication for which the use in children has not been approved by the FDA. It is not a well known and well tolerated medication. It causes severe pain, fatigue, diarrhea and nausea. The use of methotrexate should be restricted to those who are eligible and are being monitored regularly. Its effect is to bind with the folate pathway to stop cells from dividing rapidly and to destroy the cancer quickly. The most effective cancer treatment is to eradicate the cancer before it can grow and metastasize. This is the reason it is used so extensively in cancer.

Anonymous Patient Answer

What are the common side effects of methotrexate?

Side effects of methotrexate can be classified into several types of disturbances in the functioning of the liver, muscle, immune system, and joints. Side effects due to methotrexate should then be prevented/managed to a large extent.

Anonymous Patient Answer

What is the average age someone gets glioma?

Glioma is diagnosed at an average age of 46 years with 54% of patients living beyond 5 years past the diagnosis of glioma. This age point is comparable with other reports in children while the age point at which glioma occurs is earlier than reported. The peak occurrence is seen in patients in their 40s. Further, the male patients are diagnosed in an earlier age. Therefore, it is suggested that early diagnosis of this disease (prevention and treatment) is much more necessary in male population.

Anonymous Patient Answer
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