MRI-Guided Radiation for Glioblastoma

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

34 Participants Needed

Trial Summary

What is the purpose of this trial?

This pilot clinical trial studies the side effects of spectroscopic magnetic resonance imaging (MRI)-guided radiation therapy and how well it works in treating patients with newly-diagnosed glioblastoma or gliosarcoma. Spectroscopic MRI can show doctors where the extent of tumor is in the brain beyond current clinical MRI scans by mapping areas of high tumor metabolism. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Spectroscopic MRI-guided radiation therapy may work better in treating patients with glioblastoma or gliosarcoma.

Research Team

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

Principal Investigator

Emory University/Winship Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+