Plerixafor After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed High Grade Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01977677
Recruitment Status : Active, not recruiting
First Posted : November 7, 2013
Last Update Posted : July 28, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Stanford University

Brief Summary:
This pilot phase I/II trial studies the side effects and best dose of plerixafor after radiation therapy and temozolomide and to see how well it works in treating patients with newly diagnosed high grade glioma. Plerixafor may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill tumor cells. Giving plerixafor after radiation therapy and temozolomide may be an effective treatment for high grade glioma.

Condition or disease Intervention/treatment Phase
Adult Ependymoblastoma Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Adult Medulloblastoma Adult Mixed Glioma Adult Oligodendroglial Tumors Adult Pineoblastoma Adult Supratentorial Primitive Neuroectodermal Tumor (PNET) Radiation: radiation therapy Drug: temozolomide Drug: plerixafor Other: laboratory biomarker analysis Other: pharmacological study Phase 1 Phase 2

Detailed Description:


I. To assess the safety of using continuous infusion Plerixafor subsequent to irradiation in patients with newly diagnosed glioblastoma multiforme (GBM).

II. To assess the efficacy of Plerixafor as measured by progression free survival at 6 months (PFS6) from the start of irradiation.

OUTLINE: This is a phase I, dose-escalation study of plerixafor followed by a phase II study.

Within 4 weeks of surgery, patients undergo radiation therapy and receive temozolomide orally (PO) over 42 days. Beginning 8 days prior to completion of chemoradiotherapy, patients receive plerixafor intravenously (IV) continuously for 2-4 weeks. Patients also receive temozolomide PO 5 days a month beginning 35 days after completion of radiation therapy.

After completion of study treatment, patients are followed up every 12 weeks for 5 years.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Local Field Irradiation and Temozolomide Followed by Continuous Infusion Plerixafor as an Upfront Therapy for Newly Diagnosed Glioblastoma GBM
Study Start Date : November 2014
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : November 2022

Arm Intervention/treatment
Experimental: Treatment (radiation therapy, temozolomide, plerixafor)
Within 4 weeks of surgery, patients undergo radiation therapy and receive temozolomide PO over 42 days. Beginning 8 days prior to completion of chemoradiotherapy, patients receive plerixafor IV continuously for 2-4 weeks. Patients also receive temozolomide PO 5 days a month beginning 35 days after completion of radiation therapy.
Radiation: radiation therapy
Undergo radiation therapy
Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation
Drug: temozolomide
Given PO
Other Names:
  • SCH 52365
  • Temodal
  • Temodar
  • TMZ
Drug: plerixafor
Given IV
Other Names:
  • AMD 3100
  • Mozobil
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies

Primary Outcome Measures :
  1. Dose-limiting toxicity, defined as the absence of cardiac arrhythmia measured by electrocardiogram (ECG) or grade III or IV adverse events, using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 30 days post plerixafor ]
    Adverse events and qualifying dose limiting toxicity (DLT) will be tabulated by cohort, site and severity.

Secondary Outcome Measures :
  1. Progression free survival based on the Response Assessment for Neuro-Oncology (RANO) criteria, using both clinical examinations and MRIs with and without contrast [ Time Frame: At 6 months ]
    Summarized with Kaplan Meier estimates.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have tissue confirmation of high grade (WHO Grade IV) glioma including but not limited to glioblastoma, gliosarcoma, glioblastoma with oligodendroglial features, glioblastoma with PNET features.
  • The patient must have post-operative contrast enhanced imaging (CT or MRI) unless only biopsy performed (in which case post-operative imaging is not routinely obtained. In these patients, 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 chemoradiation as specified in the protocol.
  • For those patients in which steroids are clinically indicated, there must be a stable or decreasing dose of steroid medication for ≥ one week prior to the start of infusion.
  • Patients must be between the ages of 18 and 75 years old.
  • Patients must have Karnofsky Performance score ≥ 60.
  • Adequate organ function is needed at time of screening visit including:

    • ANC ≥ 1500
    • Platelets ≥ 100,000 ml
    • Serum Creatinine ≤ 1.5mg/dl; Cr Clearance should be >50 mL/min
    • AST and ALT ≤ 3 times the upper limit of normal
    • If female of childbearing potential, negative pregnancy test
  • 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 or arrhythmia
  • Prior malignancy except previously diagnosed and definitively treated more than 3 years prior to trial or whose prognosis is deemed good enough to not warrant surveillance
  • Prior sensitivity to Plerixafor
  • Pregnant or patients who are breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01977677

United States, California
Stanford University, School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Cancer Institute (NCI)
Principal Investigator: Lawrence Recht Stanford University Hospitals and Clinics

Responsible Party: Stanford University Identifier: NCT01977677     History of Changes
Other Study ID Numbers: BRN0023
NCI-2013-02012 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
BRN0023 ( Other Identifier: Stanford University Hospitals and Clinics )
P30CA124435 ( U.S. NIH Grant/Contract )
First Posted: November 7, 2013    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
JM 3100
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents