Radiation + Temozolomide for Glioblastoma

Recruiting in Palo Alto (17 mi)

Overseen ByShiao Woo, MD

Age: 65+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: University of Louisville

No Placebo Group

Trial Summary

What is the purpose of this trial?In this study we propose to determine outcomes of patients age 70 or older treated with radiation over 2 weeks given with temozolomide 75 mg/m2 daily during radiotherapy and as a post radiation treatment of 150 mg/m2 - 200 mg /m2 for 6 cycles or until the disease progresses.

Eligibility Criteria

This trial is for patients over 70 with newly diagnosed glioblastoma who haven't had prior treatments. They must have a life expectancy of more than 6 months, good organ and marrow function, and be able to consent. Excluded are those with other cancers (unless low risk or certain types within the past 5 years), severe illnesses, or HIV on antiretrovirals.

Inclusion Criteria

Patients must have normal organ and marrow function: Leukocytes > 3,000/microliter, Absolute neutrophil count > 1,500/microliter, Platelets > 100,000/microliter, Total bilirubin within normal institutional limits, aspartate aminotransferase test(SGOT)/alanine aminotransferase test(SGPT) < 2.5 X institutional upper limit of normal, Creatinine within normal institutional limits or creatinine clearance > 60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal, Ability to understand and the willingness to sign a written informed consent document

My diagnosis is glioblastoma or gliosarcoma confirmed by tissue analysis.

My tumor's MGMT promoter methylation status has been checked.

I am over 70 years old.

I am mostly independent and can care for myself.

I have not received any treatment for glioblastoma multiforme.

Exclusion Criteria

I have not had chemotherapy wafers placed during surgery.

I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

I am HIV-positive and not on antiretroviral therapy.

Participant Groups

The study tests a combination of short-term radiation therapy (over two weeks) and Temozolomide chemotherapy during and after radiation in older adults. The goal is to see how well they tolerate this treatment regimen and its effectiveness against their brain cancer.

1Treatment groups

Experimental Treatment

Group I: Hypofractionated radiotherapy and temozolomideExperimental Treatment2 Interventions

All subjects will receive treatment as is a single arm study. Two weeks of combined hypofractionated radiotherapy with concurrent temozolomide followed by up to 6 cycles of adjuvant temozolomide treatment.

Hypofractionated radiotherapy is already approved in European Union, United States, Japan for the following indications:

🇪🇺 Approved in European Union as Hypofractionated radiotherapy for: