A Phase 2 interventional study of Plerixafor and Temozolomide in Glioblastoma, Glioblastoma With Primitive Neuronal Component and Gliosarcoma, sponsored by Lawrence D Recht. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-11-14.
Sponsored by Lawrence D Recht · Phase 2, Interventional, and Treatment
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.
PRIMARY OBJECTIVES:
I. 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:
I. 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.
Exclusion Criteria:
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.
Drug: Plerixafor · Drug: Temozolomide · Radiation: Whole-Brain Radiotherapy (WBRT) · Radiation: Radiation Therapy
Plerixafor will be administered via infusion at 400 micrograms per kilogram per day for four weeks beginning one week before the end of radiation
Also known as: AMD 3100, JM-3100, Mozobil, SDZ SID 791
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.
Also known as: 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, Methazolastone, RP-46161, SCH 52365, Temcad, Temodal, Temodar, Temomedac
Undergo Whole brain radiotherapy (WBRT) - Radiotherapy consists of 30 Gy in 15 fractions of whole brain radiations
Also known as: WBRT, whole-brain radiation therapy, whole-brain radiotherapy
Radiotherapy consists of 30 Gy in 15 fractions
Also known as: XRT, RT
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.
Time frame: 6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 5 years
| Milestone | Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy |
|---|---|
| Started | 17 |
| On treatment | 17 |
| Completed treatment | 17 |
| Completed | 0 |
| Not completed | 17 |
| Withdrew: In follow up | 2 |
| Withdrew: Death | 15 |
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.
| Proportion of participants | Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy |
|---|---|
| Proportion of Progression Free Survival Participants (PFS) at Six Months | 0.786 (0.598 to 1.0) |
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.
| days | Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy |
|---|---|
| Median Survival | 398 ± 0.134 |
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.
| Participants | Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy |
|---|---|
| Grade 3 or higher AE | 3 |
| Related to WBRT treatment | 1 |
| Related to Plerixafor treatment | 0 |
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.
| Participants | Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy |
|---|---|
| In Field Occurrence | 12 |
| Out-of-field Occurrence | 2 |
Collected over All-Cause Mortality monitored/assessed up to 31 months. Serious and Other (Not Including Serious) Adverse Events were monitored/assessed 30 days after the completion of 28-day Plerixafor infusion.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy | 15/17 (88.2%) | 3/17 (17.6%) | 16/17 (94.1%) |
| Event | Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy |
|---|---|
| DepressionPsychiatric disorders | 1/17 |
| Cerebral EdemaNervous system disorders | 1/17 |
| Pseudo ProgessionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/17 |
| Disease ProgressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/17 |
| Event | Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy |
|---|---|
| NauseaGastrointestinal Disorders | 12/17 |
| FatigueGeneral Disorders | 11/17 |
| AlopeciaSkin and subcutaneous tissue disorders | 10/17 |
| VomitingGastrointestinal Disorders | 6/17 |
| Lymphocyte count decreasedInvestigations | 6/17 |
| DiarrheaGastrointestinal Disorders | 5/17 |
| HeadacheNervous System Disorders | 5/17 |
| ConstipationGastrointestinal Disorders | 4/17 |
| Platelet count decreasedInvestigations | 4/17 |
| DizzinessNervous System Disorders | 4/17 |
| Age, Customized(Participants) | Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy |
|---|---|
| 18 to 30 years | 1 |
| 31 to 39 years | 1 |
| 40 to 49 years | 3 |
| 50 to 59 years | 6 |
| 60 to 69 years | 4 |
| 70 to 79 years | 2 |
| Sex: Female, Male(Participants) | Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy |
|---|---|
| Female | 9 |
| Male | 8 |
| Ethnicity (NIH/OMB)(Participants) | Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 15 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 3 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 14 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy |
|---|---|
| United States | 17 |
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