Temozolomide for Glioblastoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Glioblastoma+2 More
Temozolomide - Drug
Eligibility
65+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing how well 18F-DOPA-PET/MRI works in imaging elderly patients with newly diagnosed grade IV malignant glioma or glioblastoma during planning for a short course of proton beam radiation therapy.

Eligible Conditions
  • Glioblastoma
  • Glioma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to 5 years post treatment

Month 12
Progression free survival
Month 12
Overall survival (OS)
Year 5
Progression Free Survival
Year 5
Differences in proton radiation planning
Incidence of adverse events (AEs)
Quality of life (QOL)
Radiotherapy (RT) treatment volumes

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)
1 of 1
Experimental Treatment

43 Total Participants · 1 Treatment Group

Primary Treatment: Temozolomide · No Placebo Group · Phase 2

Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)Experimental Group · 8 Interventions: Computed Tomography, Magnetic Resonance Imaging, Temozolomide, Fluorodopa F 18, Quality-of-Life Assessment, Questionnaire Administration, Positron Emission Tomography, Proton Beam Radiation Therapy · Intervention Types: Procedure, Procedure, Drug, Other, Other, Other, Procedure, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~3410
Magnetic Resonance Imaging
2017
Completed Phase 2
~1100
Temozolomide
FDA approved
Positron Emission Tomography
2008
Completed Phase 2
~2820
Proton Beam Radiation Therapy
2013
Completed Phase 2
~50

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years post treatment

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
12,990 Previous Clinical Trials
41,298,845 Total Patients Enrolled
301 Trials studying Glioblastoma
22,395 Patients Enrolled for Glioblastoma
Mayo ClinicLead Sponsor
2,892 Previous Clinical Trials
3,698,694 Total Patients Enrolled
9 Trials studying Glioblastoma
266 Patients Enrolled for Glioblastoma
Sujay A VoraPrincipal InvestigatorMayo Clinic

Eligibility Criteria

Age 65+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You provide informed written consent.
You have an eGFR of 60 mg/min/1.72 m^2 or greater.
You are a male and have an ECOG performance status of 0, 1, 2.
You are willing to sign a release of information for any radiation and/or follow-up records.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 21st, 2021

Last Reviewed: October 11th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.