WBRT + Temozolomide + Plerixafor for Brain Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of whole brain radiation, standard chemotherapy (temozolomide), and an additional drug (plerixafor) in patients with glioblastoma. The treatment aims to kill tumor cells and prevent them from returning. Plerixafor has shown promising results in combination with radiation therapy for glioblastoma, including an impressive increase in local tumor control.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, it does mention that you cannot have prior or concurrent treatment with Avastin (bevacizumab) or prior exposure to plerixafor.
Is the combination of whole-brain radiotherapy and temozolomide safe for humans?
What makes the drug combination of WBRT, Temozolomide, and Plerixafor unique for treating brain cancer?
This treatment is unique because it combines whole-brain radiotherapy (WBRT) with Temozolomide, a drug that can cross the blood-brain barrier, potentially enhancing the effectiveness of radiation therapy. The addition of Plerixafor, which is not commonly used in standard treatments for brain metastases, may offer a novel approach to improving outcomes.24567
What data supports the effectiveness of the drug combination of WBRT, Temozolomide, and Plerixafor for brain cancer?
Research shows that combining whole-brain radiotherapy (WBRT) with temozolomide (TMZ) is effective for treating brain metastases in non-small-cell lung cancer and melanoma, suggesting potential benefits for brain cancer treatment. Temozolomide has also shown activity in treating various types of brain tumors, including gliomas.12689
Who Is on the Research Team?
Lawrence Recht, MD
Principal Investigator
Stanford Cancer Institute Palo Alto
Are You a Good Fit for This Trial?
This trial is for patients with high-grade gliomas, including glioblastoma. They must have had surgery but no other cancer treatments and should be in good enough health to understand the study and give consent. Key requirements include normal liver function tests, adequate kidney function, a negative pregnancy test for women of childbearing age, and an agreement to use effective contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgical Resection
Patients undergo maximal safe surgical resection
Radiation Therapy
Patients undergo radiation therapy for 42 days, initiating whole brain radiation therapy at day 21
Chemotherapy
Patients receive temozolomide daily on days 1-42
Plerixafor Infusion
Patients receive plerixafor by continuous infusion on days 1-28
Maintenance Chemotherapy
Patients receive temozolomide monthly for 6-12 courses
Follow-up
Participants are monitored for adverse events for 30 days after the last dose of Plerixafor and then every 12 weeks for 5 years for survival follow-up
What Are the Treatments Tested in This Trial?
Interventions
- Plerixafor
- Radiation Therapy
- Temozolomide
- Whole-Brain Radiotherapy (WBRT)
Temozolomide is already approved in European Union, United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lawrence D Recht
Lead Sponsor
Sanofi
Industry Sponsor
Paul Hudson
Sanofi
Chief Executive Officer since 2019
Degree in Economics from Manchester Metropolitan University
Christopher Corsico
Sanofi
Chief Medical Officer
MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University