MRI-Guided Radiation for Glioblastoma

No longer recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Emory University

Must not be taking: Investigational agents

Disqualifiers: Pacemakers, Other cancers, Prior radiation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special kind of MRI-guided radiation therapy is more effective for treating brain tumors like glioblastoma or gliosarcoma. The MRI used in this trial provides a clearer view of the tumor, enabling doctors to target it more precisely with radiation to kill tumor cells. Participants will receive dose-escalated radiation therapy along with temozolomide, a standard drug for these tumors. Individuals recently diagnosed with glioblastoma or gliosarcoma who can undergo MRI scans may be suitable candidates for this trial. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in brain tumor therapy.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking other treatments for your tumor while participating in this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that advanced imaging can safely guide higher doses of radiation therapy for people with newly diagnosed glioblastoma, a type of brain cancer. Studies have found that increasing the radiation dose to 75 Gy with this technique is possible and generally well-tolerated, with no major safety issues reported.

Temozolomide, a common chemotherapy drug used with radiation therapy, has proven effective and safe. Research indicates that temozolomide not only improves survival rates but is also safe for older adults. Overall, both imaging-guided radiation and temozolomide have strong safety records based on existing research. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this treatment because it combines advanced imaging technology with targeted radiation therapy for glioblastoma, a type of brain cancer. Unlike traditional radiation treatments, this approach uses spectroscopic magnetic resonance imaging (sMRI) to guide dose-escalated radiation therapy, allowing for more precise targeting of the tumor while sparing healthy brain tissue. Additionally, the treatment is administered alongside temozolomide, a standard chemotherapy drug, and aims to enhance its effectiveness. This innovative method has the potential to improve outcomes by delivering higher doses of radiation directly to the cancer cells with minimal side effects, offering new hope for patients with this aggressive condition.

What evidence suggests that this trial's treatments could be effective for glioblastoma?

This trial will evaluate the use of spectroscopic magnetic resonance imaging (sMRI) to guide dose-escalated radiation therapy for glioblastoma. Research has shown that using MRI scans to guide higher doses of radiation therapy might help treat glioblastoma, a type of brain cancer. Studies indicate that increasing the radiation dose to 75 Gy, with the help of MRI, is safe and could improve survival rates. This method targets the tumor more accurately, potentially leading to better results.

Participants in this trial will receive MRI-guided radiation therapy alongside the drug temozolomide. Combining temozolomide with radiation therapy has been proven to improve survival in glioblastoma patients. It significantly increases overall survival compared to using radiation therapy alone. This combination is a standard treatment and has effectively extended the life expectancy of those with this aggressive brain cancer. ^{1 5 6 7 8}

Who Is on the Research Team?

Hui-Kuo G. Shu, MD, PhD, FASTRO

Principal Investigator

Emory University/Winship Cancer Institute

Are You a Good Fit for This Trial?

This trial is for patients with newly-diagnosed glioblastoma or gliosarcoma who can undergo MRI scans, have not received prior brain tumor treatments, and do not have certain medical implants that affect MRI safety. They should be in a condition to forego other cancer therapies during the trial, have specific blood counts and organ function levels within set ranges, expect to live at least 12 weeks, and be able to swallow capsules.

Inclusion Criteria

Patients must have a life expectancy of ≥ 12 weeks

Patients must be able to have MRI scans

Patients must have the following lab values: White blood cell (WBC) ≥ 3,000/µL, Absolute neutrophil count (ANC) ≥ 1,500/µL, Platelet count of ≥ 75,000/µL, Hemoglobin ≥ 9.0 gm/dL (transfusion is allowed to reach minimum level), Serum glutamic-oxaloacetic transaminase (SGOT) ≤ 2.0 x upper limit of normal (ULN), Bilirubin ≤ 2 x ULN, Creatinine ≤ 1.5 mg/dL

Exclusion Criteria

I don't have any severe illnesses that can't be managed and that would stop me from handling this treatment.

Patients receiving any other investigational agents are excluded

I have been cancer-free and off treatment for any other cancer except non-melanoma skin cancer for over 3 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo sMRI-guided radiation therapy daily for the first 5 days of every week over 6 weeks and receive temozolomide orally daily during radiation therapy for up to 42 days

6 weeks

Daily visits (Monday - Friday)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up every 3 months for up to 2 years

Up to 2 years

Every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Dose-Escalated Radiation Therapy
• Spectroscopic Magnetic Resonance Imaging
• Temozolomide

Trial Overview The study tests spectroscopic MRI-guided radiation therapy combined with Temozolomide chemotherapy in treating brain tumors. Spectroscopic MRI aims to better identify tumor metabolism beyond what standard MRIs show. The goal is to see if this leads to more effective radiation treatment by targeting the tumors more precisely.

How Is the Trial Designed?

Group I: sMRI-Guided RT with TMZ Experimental Treatment 3 Interventions

Patients undergo spectroscopic magnetic resonance imaging-guided dose-escalated radiation therapy daily for the first 5 days of every week (Monday - Friday) over 6 weeks. Patients also receive standard of care temozolomide PO daily during radiation therapy for up to 42 days.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11275351/

Temozolomide (TMZ) in the Treatment of Glioblastoma ... The purpose of this paper is to describe the place of this anticancer drug and its efficacy in GBM therapy based on recent clinical trials.

2. ecog-acrin.org ecog-acrin.org/press-release-adding-the-chemotherapy-pill-temozolomide-to-radiation-therapy-improves-survival-in-adult-patients-with-glioma-a-slow-growing-type-of-brain-cancer/

Clinical trial finds that adding the chemotherapy pill ... “We found that the 10-year survival rate was 70% with the combined treatment with temozolomide chemotherapy and radiation, compared to 47% with ...

3. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-025-13757-1

The role of temozolomide as adjuvant therapy in glioblastoma ... TMZ has been shown to significantly improve patient outcomes, notably increasing the median overall survival compared to RT alone [2]. This ...

4. spandidos-publications.com spandidos-publications.com/10.3892/ol.2024.14551

Temozolomide based treatment in glioblastoma: 6 vs. 12 ... The present data suggested that extended adjuvant temozolomide appeared to be more effective than the conventional six cycles.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2375282/

A rapid and systematic review of the effectiveness of ... The key results were that temozolomide may increase progression-free survival but has no significant impact on overall length of survival. The main effect from ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9476976/

Updated systematic review and meta-analysis - PMC A meta-analysis involving 1018 patients with glioblastoma from seven studies reported statistically significant improvements in progression-free survival (PFS) ...

7. academic.oup.com academic.oup.com/noa/article/7/1/vdaf084/8120832

Second-line temozolomide in first recurrent MGMT-methylated ... Among patients receiving temozolomide only, stable disease or partial response was achieved in 53.3%, with a progression-free survival rate at 6 ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT01107522

Study Details | NCT01107522 | Safety and Tolerability of ... The purpose of this study is to determine the safety, tolerability, and the maximum tolerated dose/recommended phase II dose of carboxyamidotriazole orotate ...