Treatment for Glioblastoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Pittsburgh Medical Center, Radiation Oncology, Pittsburgh, PA
Glioblastoma
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new radiation schedule may help improve survival for individuals with glioblastoma.

See full description

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Glioblastoma

Study Objectives

This trial is evaluating whether Treatment will improve 2 primary outcomes and 3 secondary outcomes in patients with Glioblastoma. Measurement will happen over the course of From baseline up to 5 years..

Year 5
Change in Absolute Lymphocyte Count
Up to 9 years
Overall survival (OS)
Progression free survival (PFS)
Progression free survival (PFS) - 25 Gy in 5 fractions
Progression free survival (PFS) - 40 Gy in 15 fractions

Trial Safety

Safety Progress

1 of 3

Other trials for Glioblastoma

Trial Design

2 Treatment Groups

40 Gy in 15 fractions
1 of 2
25 Gy in 5 fractions
1 of 2
Active Control

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment 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 & 2 and have already been tested with other people.

40 Gy in 15 fractionsPatients randomized to 40 Gy in 15 fractions will receive 75 mg/m^2 temozolomide per day for 15 days starting the first day of radiotherapy. This treatment will be followed by standard monthly 5 day cycles at 150 mg/m^2 for upto 1 year.
25 Gy in 5 fractionsPatients randomized to 25 Gy in 5 fractions will receive 150 mg/m^2 temozolomide per day for 5 days starting the first day of radiotherapy. This treatment will be followed by standard monthly 5 day cycles at 150 mg/m^2 for upto 1 year.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 9 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 9 years for reporting.

Closest Location

University of Pittsburgh Medical Center, Radiation Oncology - Pittsburgh, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Glioblastoma. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Karnofsky Performance Status (KPS) below 60 or ECOG of 3 or 4
Any number or type of prior chemotherapy is allowed (patient may receive concurrent or adjuvant systemic therapy such as cetuximab at the discretion of the treating oncologic team).
Age ≥18 with ability to provide written informed consent
Pathologically confirmed WHO Grade IV Gliobastoma prior receiving radiotherapy
Prior radiotherapy to a dose of ≥50Gy
No signs of distant metastases
Baseline laboratory assessment including CBC and blood chemistry, ANC > or equal 1500, Platelet count greater or equal 100. Liver function tests and creatinine not greater than twice ULN.
Patient should not be pregnant. Urine or blood β-HCG within 14 days prior to study start for females who are not atleast one year post-menopausal or who have ot undergone a surgical sterilization procedure
A baseline MRI scan of the brain is required to determine how much tumor is present for properly planning patient's radiotherapy.

Patient Q&A Section

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

"A year after diagnosis, 9.4% of cases are glioblastomas. Although brain tumor surgery continues to be the best treatment, surgery alone did not significantly improve survival in our cohort of patients aged 65 or older." - Anonymous Online Contributor

Unverified Answer

What are the signs of glioblastoma?

"Some of the signs and symptoms of a glioblastoma include headache, vomiting, facial weakness, vomiting blood or change of personality. Also, some signs and symptoms include vision changes, lethargic behavior, decreased alertness and seizures. Patients with this type of brain tumour may have blood in their urine or may have pain above the eye. In addition, the symptoms of headache or visual loss may be due to a brain embolism or to swelling around part of the brain. These signs of brain cancer that may be associated with headache include a new, unexplained, persistent headache, change in the size and nature of the headache, headache that is not relieved by usual pain killers and headache that is worse with motion or bending over." - Anonymous Online Contributor

Unverified Answer

What is glioblastoma?

"It is a cancer of the brain forming from cells known as glial cells that give rise to the brain and the spinal cord. It is typically characterized by rapid onset of symptoms and is highly aggressive but can become treatable once the tumour has begun to form." - Anonymous Online Contributor

Unverified Answer

What are common treatments for glioblastoma?

"Some treatments have been established for GBM, but none has proven to be fully effective. In most cases, treatment is determined for each patient by consideration of prognosis and individual circumstances. Recent advances in molecular and targeted therapies are becoming a standard of care for patients with GBM." - Anonymous Online Contributor

Unverified Answer

What causes glioblastoma?

"Many factors contribute to the development of glioblastoma, but no single risk factor can predispose individuals to glioblastoma. Genetic predisposition, such as TP53 mutation status, and epigenetic alterations may also play roles. Exposure to radiation is also a significant risk factor; there is a significant relationship between occupational exposure to ionizing radiation and risk of developing this brain tumor. In spite of the progress made in the prevention and therapy of brain tumors, the mechanism behind glioblastomas is not well understood." - Anonymous Online Contributor

Unverified Answer

Can glioblastoma be cured?

"Due to the high recurrence, prognosis, and therapeutic costs, there is no convincing evidence that the treatment with postoperative radiotherapy of glioblastoma prevents or reduces tumour progression. However, because chemotherapy and adjuvant treatments may improve median survival and prolong survival time of the patients, such treatments should also be continued." - Anonymous Online Contributor

Unverified Answer

How serious can glioblastoma be?

"In this survey we found that a poor performance status at presentation was associated with longer survival in patients with glioblastoma. When these results are extrapolated to a broader population, patients with a poor performance status may benefit from earlier diagnosis and a more aggressive treatment." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for glioblastoma?

"In a recent study, findings shows that the overall survival of patients who have ever had open resective surgery for high-grade glioma is very low. It has a five-year survival rate at approximately 1%; no patients experienced a complete remission after surgery and virtually all patients experienced some tumor progression after resective surgery. The prognosis for newly diagnosed low-grade astrocytomas is significantly better, perhaps because of the use of aggressive multimodality therapy for glioblastoma at the time of diagnosis. In a recent study, findings indicates that patients with newly diagnosed, high-grade gliomas now have dismal survival if they undergo resective surgery." - Anonymous Online Contributor

Unverified Answer

Is treatment safe for people?

"There is no justification for withholding treatment for people with glioblastoma if the risks of treatment are considered. Treating people for 10 days is not the same as not treating them for 10 days." - Anonymous Online Contributor

Unverified Answer

How does treatment work?

"Many questions about how to treat glioblastoma remain unanswered. In some cases, the cause of the tumor was already known, including a deletion of the gene for the IKK (gene coding for the inhibitor of the IKK kinase), which leads to increased activation of the IκB kinase. In this case, treatment could target the mutated gene as well. In many other cases, there was no obvious cause. Treatment therefore focuses on the tumor itself, focusing particularly on treating the area around the tumor where it is growing. There were no differences in survival between the different treatment strategies. The treatment of choice is debated. It could be a combination of surgery and chemotherapy. It could be the chemotherapy and radiotherapy used separately." - Anonymous Online Contributor

Unverified Answer

What does treatment usually treat?

"The majority of glioblastoma patients experience a reduction in their symptoms with aggressive treatment. This supports the idea that therapy targeting tumor enhancement may not be the best option from a patient's point of view. In the absence of any demonstrable correlation between treatment modalities and pain, we can conclude that pain reduction does not seem to be a prerequisite for treatment. More research in this area is needed to clarify how the patient's mood might influence the patient's pain and consequently the willingness to proceed with treatment." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets glioblastoma?

"Median age at diagnosis of patients with glioblastoma is 59 years. We anticipate that there will be an average age shift over time in the average age of patients with glioblastoma. Older patients with glioblastoma should be a priority for intensified research efforts in developing new treatment options and new patient support programs for this malignant condition." - Anonymous Online Contributor

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