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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.
 
ClinicalTrials.gov Identifier: NCT01977677
Recruitment Status : Completed
First Posted : November 7, 2013
Results First Posted : July 3, 2018
Last Update Posted : October 23, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Lawrence Recht, 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:

PRIMARY OBJECTIVES:

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.

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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
Actual Primary Completion Date : November 2017
Actual Study Completion Date : September 2018


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 [ Time Frame: Up to 30 days post plerixafor ]
    Dose Limiting Toxicity is defined as defined as any hematologic or on-hematologic adverse events grade 3 or higher using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 with a suspected causal relationship to Plerixafor (including electrocardiogram changes indicative of ischemia, ventricular tachycardia)

  2. Participants Alive and Without Disease Progression At 6 Months After the Start of the Irradiation [ Time Frame: 6 months from start of irradiation ]
    Progression free survival based on the Response Assessment for Neuro-Oncology (RANO) criteria, using both clinical examinations and MRIs with and without contrast 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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT01977677


Locations
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United States, California
Stanford University, School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Lawrence Recht
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Lawrence Recht Stanford University Hospitals and Clinics
  Study Documents (Full-Text)

Documents provided by Lawrence Recht, Stanford University:

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Responsible Party: Lawrence Recht, Professor of Neurology, Stanford University
ClinicalTrials.gov Identifier: NCT01977677    
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
Results First Posted: July 3, 2018
Last Update Posted: October 23, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Glioblastoma
Glioma
Gliosarcoma
Medulloblastoma
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Pinealoma
Sarcoma, Ewing
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms
Astrocytoma
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
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Sarcoma
Plerixafor octahydrochloride
Temozolomide