70 Participants NeededMy employer runs this trial

Pre-Radiation Chemotherapy for Brain Cancer

(PRC Trial)

Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: The Cooper Health System
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

Better treatments are needed for high-grade gliomas (HGG), and new ways of treating this disease should be tested. The investigators want to see if giving medicine before radiation works well. After radiation, MRI scans can be harder to understand because radiation changes how the brain looks on the scan. If new medicines are given before radiation, the scans are easier to read.

First, the investigators need to find out if giving chemotherapy early works using a drug we already know can treat gliomas. The investigators will start with temozolomide, which is the only chemotherapy approved by the FDA for HGG. If this approach is successful, the investigators can then test new drugs using this screening method.

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with a newly diagnosed high-grade brain tumor (like glioblastoma) who still have some tumor left after surgery, are well enough to participate, and do not need urgent radiation or chemo. Participants must be able to take oral medication and agree to use birth control if needed.

Inclusion Criteria

Willingness to comply with all study procedures and availability for the duration of the study
For females of reproductive potential: use of highly effective contraception for at least 1 week prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of pre-radiation temozolomide administration
I can care for myself and do normal activities with little help.
See 9 more

Exclusion Criteria

I have had a Gliadel wafer or similar local therapy placed during my tumor surgery.
Patients receiving any other investigational agents
I am not pregnant.
See 3 more

What Are the Treatments Tested in This Trial?

Interventions

  • Temozolomide

Trial Overview

The study tests giving the chemotherapy drug temozolomide before starting radiation in people with high-grade gliomas. The goal is to see if early chemo helps treatment and makes MRI scans easier to interpret before any changes from radiation appear.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: All PatientsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Cooper Health System

Lead Sponsor

Trials
82
Recruited
35,600+

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborator

Trials
578
Recruited
33,600+

University of Virginia

Collaborator

Trials
802
Recruited
1,342,000+

Virginia Commonwealth University

Collaborator

Trials
732
Recruited
22,900,000+

Wake Forest University

Collaborator

Trials
193
Recruited
151,000+

Georgetown University

Collaborator

Trials
355
Recruited
142,000+

Musella Foundation

Collaborator

Trials
2
Recruited
10+

Imaging Biometrics, LLC

Industry Sponsor

Trials
1

West Virginia University

Collaborator

Trials
192
Recruited
64,700+