Loading clinical trials...

A Study Using Radiation Therapy and Temozolomide to Treat Glioblastoma in Patients Over 70 | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

A Study Using Radiation Therapy and Temozolomide to Treat Glioblastoma in Patients Over 70

A Phase I/ II Study of Hypofractionated Radiotherapy With Concurrent Temozolomide Followed by Adjuvant Temozolomide in Patients Over 70 Years Old With Newly Diagnosed Glioblastoma

NCT01985087•University of Louisville

View on ClinicalTrials.gov

Summary

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

Age

70 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Participants must have histologically confirmed glioblastoma/gliosarcoma.
•2. Tumor o6-methylguanine-DNA-methyltransferase promoter methylation status must be determined
•3. Participants must not have had any prior therapy for glioblastoma multiforme including radiation or chemotherapy.
•4. Participants must be \> 70 years of age.
•5. Participants must have life expectancy greater than 6 months.
•6. Karnofsky performance status \> 60 (ECOG \< 2).
•7. Patients must have normal organ and marrow function
•* Leukocytes \> 3,000/microliter
•* Absolute neutrophil count \> 1,500/microliter
•* Platelets \> 100,000/microliter
+5 more criteria

Exclusion Criteria

•1. Participants may not be receiving any other study agents.
•2. Participants may not have had chemotherapy wafer placement at surgery.
•3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide.
•4. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Locations (1)

James Graham Brown Cancer Center

Louisville, Kentucky, United States

Key Dates

Start Date

September 1, 2014

Primary Completion Date

May 1, 2025

Completion Date

May 1, 2025

Last Updated

October 31, 2024

Enrollment

ACTUAL participants

Conditions

Glioblastoma

Interventions

Hypofractionated radiotherapy

RADIATION

Temozolomide

DRUG

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

View study

RECRUITING

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

NCT00083512

Glioblastoma Multiforme

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 31, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study Using Radiation Therapy and Temozolomide to Treat Glioblastoma in Patients Over 70

Inclusion Criteria

Exclusion Criteria

Targeted Pediatric High-Grade Glioma Therapy

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma

EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma

Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma