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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

Tracking Information
First Submitted Date  ICMJE October 31, 2013
First Posted Date  ICMJE November 7, 2013
Results First Submitted Date  ICMJE June 5, 2018
Results First Posted Date  ICMJE July 3, 2018
Last Update Posted Date October 23, 2018
Study Start Date  ICMJE November 2014
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2018)
  • 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)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 6, 2013)
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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2013)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Plerixafor After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed High Grade Glioma
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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)
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Radiation: radiation therapy
  • Drug: temozolomide
  • Drug: plerixafor
  • Other: laboratory biomarker analysis
  • Other: pharmacological study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 25, 2017)
30
Original Estimated Enrollment  ICMJE
 (submitted: November 6, 2013)
29
Actual Study Completion Date  ICMJE September 2018
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01977677
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lawrence Recht, Stanford University
Study Sponsor  ICMJE Lawrence Recht
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Lawrence Recht Stanford University Hospitals and Clinics
PRS Account Stanford University
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP