Purpose of this Study
This study is for people with a kind of brain cancer called GBM. They will be placed into one of two treatment groups—either a regular treatment or a new one being tested. The study has two parts. In the first part, doctors choose treatments based on how well they are working for others with similar cancer. In the second part, treatments that look helpful are tested more closely.
People in the study will have brain scans every 6 to 8 weeks to check the size of the tumor. They will also have blood tests, physical check-ups, and answer questions about how they feel. Some people may take tests to check their thinking and memory. Treatment will continue until the cancer gets worse or the side effects become too strong.
Regular treatments include radiation and a medicine called temozolomide for people who are newly diagnosed. For people whose cancer has come back, the treatment is a chemotherapy medicine called lomustine.
Who Can Participate?
Eligibility
People may be able to join this study if they are 18 years or older and have a type of brain cancer called glioblastoma that is IDH wild-type. For those who are newly diagnosed, they must not have had any treatment yet. For those whose cancer has come back, it must be the first or second time. They must be taking only a small amount of steroids, feel well enough to do daily activities, and have normal lab test results. They must not be pregnant and must agree to use birth control if they could have children.
People cannot join if they have already had treatment for glioblastoma (for newly diagnosed patients), have serious problems with their heart, liver, or kidneys, have infections or diseases that affect the immune system, or are taking certain medicines like warfarin or herbal supplements.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is testing different treatments for glioblastoma (GBM). The goal is to find out which treatments help people live longer and feel better, and to match the best treatments to specific types of GBM.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
GBM AGILE Global Adaptive Trial
Principal Investigator
Katherine
Peters
Protocol Number
PRO00104267
NCT ID
NCT03970447
Phase
II/III
Enrollment Status
Open to Enrollment