Whole Brain Radiation Therapy With Standard Temozolomide Chemo-Radiotherapy and Plerixafor in Treating Patients With Glioblastoma

NCT03746080 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: IRB-46410NCI-2018-02159BRN0037
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Glioblastoma; Glioblastoma With Primitive Neuronal Component; Gliosarcoma; Malignant Glioma; Oligodendroglial Component Present

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (3)

• Median Survival

  up to 31 months

• Toxicity Associated With Plerixafor/WBRT

  30 days

• Patterns of Treatment Failure

  5 years

Study Arms (1)

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.

Drug: Plerixafor; Drug: Temozolomide; Radiation: Whole-Brain Radiotherapy (WBRT); Radiation: Radiation Therapy

Interventions

Plerixafor DRUG

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

Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy

Temozolomide DRUG

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

Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy

Whole-Brain Radiotherapy (WBRT) RADIATION

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

Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy

Radiation Therapy RADIATION

Radiotherapy consists of 30 Gy in 15 fractions

Also known as: XRT, RT

Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lawrence D Recht: lead
• Sanofi: collaborator

Study Sites (1)

Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Glioblastoma; Gliosarcoma; Glioma

Interventions

plerixafor; ferric pyrophosphate; Temozolomide; Radiotherapy

Condition Hierarchy (Ancestors)

Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Results Point of Contact

• Title: Lawrence Recht, MD
• Organization: Stanford University

lrecht@stanford.edu

(650) 725-8630

Study Officials

• Lawrence Recht

  Stanford Cancer Institute Palo Alto

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: November 19, 2018
• Study Start: December 4, 2018
• Primary Completion: May 31, 2022
• Study Completion: February 8, 2024
• Last Updated: November 14, 2025
• Results First Posted: June 26, 2024

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)