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

NCT ID: NCT03746080

Last Updated: 2025-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-04
• Study Completion Date: 2024-02-08

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.

Detailed Description

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy

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.

Group Type: EXPERIMENTAL

Plerixafor

Intervention Type: 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

Temozolomide

Intervention Type: 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.

Whole-Brain Radiotherapy (WBRT)

Intervention Type: RADIATION

Undergo Whole brain radiotherapy (WBRT) - Radiotherapy consists of 30 Gy in 15 fractions of whole brain radiations

Radiation Therapy

Intervention Type: RADIATION

Radiotherapy consists of 30 Gy in 15 fractions

Interventions

Plerixafor

Plerixafor will be administered via infusion at 400 micrograms per kilogram per day for four weeks beginning one week before the end of radiation

Intervention Type: DRUG

Temozolomide

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.

Intervention Type: DRUG

Whole-Brain Radiotherapy (WBRT)

Undergo Whole brain radiotherapy (WBRT) - Radiotherapy consists of 30 Gy in 15 fractions of whole brain radiations

Intervention Type: RADIATION

Radiation Therapy

Radiotherapy consists of 30 Gy in 15 fractions

Intervention Type: RADIATION

Other Intervention Names

AMD 3100; JM-3100; Mozobil; SDZ SID 791; 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; WBRT; whole-brain radiation therapy; whole-brain radiotherapy; XRT; RT

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Lawrence D Recht

OTHER

Sponsor Role: lead

Responsible Party

Lawrence D Recht

Professor of Neurology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lawrence Recht

Role: PRINCIPAL_INVESTIGATOR

Stanford Cancer Institute Palo Alto

Locations

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NCI-2018-02159

Identifier Type: REGISTRY

Identifier Source: secondary_id

BRN0037

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-46410

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-46410

Identifier Type: -

Identifier Source: org_study_id