GlioblastomaPhase 2NCT03746080
Whole Brain Radiation Therapy With Standard Temozolomide Chemo-Radiotherapy and Plerixafor in Treating Patients With Glioblastoma
A Phase 2 study testing Plerixafor, Temozolomide and Whole-Brain Radiotherapy (WBRT) in people with Glioblastoma and Glioblastoma With Primitive Neuronal Component, run by Lawrence D Recht at 1 site in United States.
Trial summary
This phase II trial studies how well whole brain radiation therapy works with standard temozolomide chemo-radiotherapy and plerixafor in treating patients with glioblastoma (brain tumor). Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glioblastoma, Glioblastoma With Primitive Neuronal Component, Gliosarcoma
- What is being tested?
- Plerixafor, Temozolomide and Whole-Brain Radiotherapy (WBRT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2018to 8 Feb 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Absolute neutrophil count (ANC) >= 1500 (at time of screening).
- Platelets >= 100,000 ml (at time of screening).
Show all 12Show fewer
- Serum creatinine =< 1.5mg/dl (at time of screening).
- Creatinine (Cr) clearance should be > 50 mL/min (at time of screening).
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 times the upper limit of normal (at time of screening).
- If female of childbearing potential, negative pregnancy test (at time of screening).
- The patient or his/her legal representative must have the ability to understand and willingness to sign a written informed consent document.
- Patient agrees to use an effective method of contraception (hormonal or two barrier methods) while on study and for at least 3 months following the plerixafor infusion.
Who cannot join
- 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.
- Prior malignancy except for non-melanoma skin cancer and carcinoma in situ (of the cervix or bladder), unless diagnosed and definitively treated more than 3 years prior to 1st dose of investigational drug.
- Prior sensitivity to plerixafor.
- Pregnant or patients who are breastfeeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304
About this study
Official title: A 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
This phase II trial studies how well whole brain radiation therapy works with standard temozolomide chemo-radiotherapy and plerixafor in treating patients with glioblastoma (brain tumor). Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Plerixafor is a drug that may prevent recurrence of glioblastoma after radiation treatment. Giving whole brain radiation therapy with standard temozolomide chemo-radiotherapy and plerixafor may work better in treating patients with glioblastoma.
Read the detailed description
PRIMARY OBJECTIVES:
- The primary purpose of this Phase II study is to evaluate the efficacy of Plerixafor administered with a modified radiation regimen that includes a component of WBRT. The primary endpoint is 6-month progression free survival post initiation of Chemoradiation.
SECONDARY OBJECTIVES:
- To assess the median survival of patients treated with continuous infusion plerixafor/WBRT.
II. To assess the toxicities both short and long term of continuous infusion plerixafor/WBRT.
III. To assess the patterns of failure (in and out of irradiated brain field, out of brain) of continuous infusion plerixafor/WBRT.
OUTLINE:
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 1-42. Beginning 7 days before the completion of whole brain radiation therapy, patients receive plerixafor by continuous infusion on days 1-28. Beginning 1 week after completion of plerixafor infusion and 35 days after completion of whole brain radiation therapy, patients receive temozolomide monthly for 6-12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for adverse events for 30 days after the last dose of Plerixafor and then every 12 weeks for 5 years for survival follow-up.
- Conditions
- Glioblastoma, Glioblastoma With Primitive Neuronal Component, Gliosarcoma, Malignant Glioma, Oligodendroglial Component Present
- Being tested
- Plerixafor, Temozolomide, Whole-Brain Radiotherapy (WBRT), Radiation Therapy
- Medical subject headings
- Glioblastoma, Gliosarcoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlerixaforDrug
Also called AMD 3100, JM-3100, Mozobil, SDZ SID 791
Plerixafor will be administered via infusion at 400 micrograms per kilogram per day for four weeks beginning one week before the end of radiation
TemozolomideDrug
Also called CCRG-81045, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831
Temozolomide (TMZ) will be administered concurrently with the radiation for 42 days and 6-12 cycles of monthly adjuvant Temozolomide (TMZ) after completion of Plerixafor infusion.
Whole-Brain Radiotherapy (WBRT)Radiation
Also called WBRT, whole-brain radiation therapy, whole-brain radiotherapy
Undergo Whole brain radiotherapy (WBRT) - Radiotherapy consists of 30 Gy in 15 fractions of whole brain radiations
Radiation TherapyRadiation
Also called XRT, RT
Radiotherapy consists of 30 Gy in 15 fractions
| Study group | Role | What they receive |
|---|---|---|
| Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy | 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. Receives: Drug: Plerixafor; Drug: Temozolomide; Radiation: Whole-Brain Radiotherapy (WBRT); Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Progression Free Survival Participants (PFS) at Six Months
Proportion of Progression free survival will be measured at 6 months post initiation of chemoradiation. Simon 2-stage design will be use to assess progression-free survival. Will be computed from start of induction therapy and summarized with Kaplan-Meier estimates.
Measured: 6 months
Secondary outcomes (3)
Median Survival
Median survival will be assessed at 31 months of subjects who have completed the 28 day Plerixafor infusion. Will be computed from start of induction therapy and summarized with Kaplan-Meier estimates.
Measured: up to 31 months
Toxicity Associated With Plerixafor/WBRT
Incidence of adverse events will be graded and recorded per Common Terminology Criteria for Adverse Events version 5.0. Will assess reported toxicities up until 30 days of treatment. The number of participants experiencing adverse events, including qualifying dose limiting toxicities (DLTs) will be tabulated by attribution (Unrelated, Unlikely to be related, Definitely related) and severity.
Measured: 30 days
Patterns of Treatment Failure
Patterns of Failure in patients receiving Whole Brain Radiotherapy + Plerixafor + Chemoradiotherapy was assessed by determining the out-of-field occurrence or occurrence outside of the brain over time. Local treatment failure was defined as within the 95% isodose region. Out-of-field occurrence is defined by any treatment failure observed outside treatment area.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start4 Dec 2018
- Primary completion31 May 2022
- Study completion8 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lawrence D Recht
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor-investigator, Lawrence D Recht, Stanford University
- Investigators
- Lawrence Recht, Principal investigator, Stanford Cancer Institute Palo Alto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746080
- Sponsor's protocol ID
- IRB-46410
- Other IDs
- NCI-2018-02159, BRN0037, IRB-46410
- Status last verified
- Oct 2025
- First submitted
- 7 Nov 2018
- Last updated
- 14 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 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
- ClinicalTrials.gov ID
- NCT03746080
- Acronym / sponsor ID
- IRB-46410
- Conditions
- Glioblastoma, Glioblastoma With Primitive Neuronal Component, Gliosarcoma, Malignant Glioma, Oligodendroglial Component Present
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Lawrence D RechtUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 8 Feb 2024 (actual)
- First posted
- 19 Nov 2018 (actual)
- Results
- Posted 26 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well whole brain radiation therapy works with standard temozolomide chemo-radiotherapy and plerixafor in treating patients with glioblastoma (brain tumor). Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Plerixafor is a drug that may prevent recurrence of glioblastoma after radiation treatment. Giving whole brain radiation therapy with standard temozolomide chemo-radiotherapy and plerixafor may work better in treating patients with glioblastoma.
Detailed description
PRIMARY OBJECTIVES:
- The primary purpose of this Phase II study is to evaluate the efficacy of Plerixafor administered with a modified radiation regimen that includes a component of WBRT. The primary endpoint is 6-month progression free survival post initiation of Chemoradiation.
SECONDARY OBJECTIVES:
- To assess the median survival of patients treated with continuous infusion plerixafor/WBRT.
II. To assess the toxicities both short and long term of continuous infusion plerixafor/WBRT.
III. To assess the patterns of failure (in and out of irradiated brain field, out of brain) of continuous infusion plerixafor/WBRT.
OUTLINE:
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 1-42. Beginning 7 days before the completion of whole brain radiation therapy, patients receive plerixafor by continuous infusion on days 1-28. Beginning 1 week after completion of plerixafor infusion and 35 days after completion of whole brain radiation therapy, patients receive temozolomide monthly for 6-12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for adverse events for 30 days after the last dose of Plerixafor and then every 12 weeks for 5 years for survival follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy | Experimental | Drug: Plerixafor, Drug: Temozolomide, Radiation: Whole-Brain Radiotherapy (WBRT), Radiation: Radiation TherapyAfter 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
- Absolute neutrophil count (ANC) >= 1500 (at time of screening).
Key exclusion criteria (7 listed)
- 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.
- Prior malignancy except for non-melanoma skin cancer and carcinoma in situ (of the cervix or bladder), unless diagnosed and definitively treated more than 3 years prior to 1st dose of investigational drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlerixaforAlso: AMD 3100, JM-3100, Mozobil, SDZ SID 791Plerixafor will be administered via infusion at 400 micrograms per kilogram per day for four weeks beginning one week before the end of radiation | Drug | Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy |
| TemozolomideAlso: CCRG-81045, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831Temozolomide (TMZ) will be administered concurrently with the radiation for 42 days and 6-12 cycles of monthly adjuvant Temozolomide (TMZ) after completion of Plerixafor infusion. | Drug | Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy |
| Whole-Brain Radiotherapy (WBRT)Also: WBRT, whole-brain radiation therapy, whole-brain radiotherapyUndergo Whole brain radiotherapy (WBRT) - Radiotherapy consists of 30 Gy in 15 fractions of whole brain radiations | Radiation | Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy |
| Radiation TherapyAlso: XRT, RTRadiotherapy consists of 30 Gy in 15 fractions | Radiation | Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy |
Primary outcome
Proportion of Progression Free Survival Participants (PFS) at Six Months
Time frame: 6 months
Proportion of Progression free survival will be measured at 6 months post initiation of chemoradiation. Simon 2-stage design will be use to assess progression-free survival. Will be computed from start of induction therapy and summarized with Kaplan-Meier estimates.
3 secondary outcomes
Median Survival
Time frame: up to 31 months
Toxicity Associated With Plerixafor/WBRT
Time frame: 30 days
Patterns of Treatment Failure
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Recht principal investigator
Stanford Cancer Institute Palo Alto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Plerixafor, Temozolomide and Whole-Brain Radiotherapy (WBRT) in people with Glioblastoma and Glioblastoma With Primitive Neuronal Component, run by Lawrence D Recht at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Progression Free Survival Participants (PFS) at Six Months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.