Completed

Whole Brain Radiotherapy Addition to Temozolomide and Plerixafor in Glioblastoma

Study Aim

This study aims to evaluate if adding whole brain radiotherapy to temozolomide and plerixafor can improve survival without disease progression for six months in individuals with glioblastoma.

What is being tested

Plerixafor

+ Temozolomide

+ Whole-Brain Radiotherapy (WBRT)

DrugRadiation

Who is being recruted

Astrocytoma+8

+ Glioblastoma

+ Glioma

From 18 to 75 Years

+19 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: December 2018

See protocol details

Summary

Principal SponsorLawrence D Recht

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: December 4, 2018

Actual date on which the first participant was enrolled.

This study is designed to find out if adding whole brain radiotherapy (WBRT) to the usual treatment for newly diagnosed glioblastoma, which is a type of brain cancer, improves patient outcomes. It focuses on using a drug called Plerixafor, alongside the common chemotherapy drug Temozolomide. The main aim is to see if this combination helps patients live without the cancer getting worse for at least six months after starting treatment. Researchers are also looking at how long patients live overall and any side effects that might occur, to see if this new approach is a safe and effective way to treat glioblastoma. Participants who have had the most tumor removed through surgery will receive radiation therapy over 42 days. They will start WBRT on the 21st day of their radiation treatment. During this time, they will take Temozolomide every day. Seven days before finishing WBRT, Plerixafor is administered through a continuous infusion for 28 days. After a short break of one week following the Plerixafor treatment and 35 days after completing WBRT, participants will continue with Temozolomide treatment monthly for 6 to 12 cycles, as long as there is no disease progression or severe side effects. After finishing the treatment, patients are monitored for any adverse effects for 30 days and are then checked every 12 weeks for up to five years to track their survival.

Official TitleA Follow-Up Study to Add Whole Brain Radiotherapy (WBRT) to Standard Temozolomide Chemo-Radiotherapy in Newly Diagnosed Glioblastoma (GBM) Treated With 4 Weeks of Continuous Infusion Plerixafor

NCT03746080

Principal SponsorLawrence D Recht

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

21 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AstrocytomaGlioblastomaGliomaNeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroectodermal TumorsNeoplasms, NeuroepithelialGliosarcoma

Criteria

12 inclusion criteria required to participate

Patients must have tissue confirmation of high grade (World Health Organization (WHO) grade IV) glioma including but not limited to glioblastoma, gliosarcoma, glioblastoma with oligodendroglial features, glioblastoma with primitive neuroectodermal tumor (PNET) features.

The patient must have post-operative contrast enhanced imaging (computed tomography [CT] or magnetic resonance imaging [MRI]) unless only biopsy performed. For patients having biopsy alone, post-operative imaging is not routinely obtained and therefore the preoperative study will serve as baseline.

Patient should have surgery (biopsy, partial resection or gross total resection) and no additional anti-cancer therapy except the chemo-radiation as specified in the protocol.

Patients must have Karnofsky performance score >= 60.

Show More Criteria

7 exclusion criteria prevent from participating

Prior or concurrent treatment with Avastin (bevacizumab).

Prior exposure to plerixafor.

Prior use of other investigational agents to treat the brain tumor.

Recent history of myocardial infarct (less than 3 months) or history of active angina.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

After completion maximal safe surgical resection, patients undergo radiation therapy for 42 days, initiating whole brain radiation therapy at day 21 (dose 16 of radiation therapy) and receive temozolomide daily on days 1 to 42. Beginning 7 days before the completion of whole brain radiation therapy, patients receive plerixafor by continuous infusion on days to 1 to 28. Beginning 1 week after completion of plerixafor infusion and 35 days after completion of whole brain radiation therapy, patients receive temozolomide monthly for 6 to 12 courses in the absence of disease progression or unacceptable toxicity.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Stanford Cancer Institute Palo Alto

Palo Alto, United StatesOpen Stanford Cancer Institute Palo Alto in Google Maps

CompletedOne Study Center