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

Last updated: September 27, 2018
Sponsor: Lawrence Recht
Overall Status: Completed

Phase

1/2

Condition

Cancer/tumors

Astrocytoma

Neurofibromatosis

Treatment

N/A

Clinical Study ID

NCT01977677
BRN0023
BRN0023
NCI-2013-02012
P30CA124435
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients must have tissue confirmation of high grade (WHO Grade IV) glioma includingbut not limited to glioblastoma, gliosarcoma, glioblastoma with oligodendroglialfeatures, glioblastoma with PNET features.

  • The patient must have post-operative contrast enhanced imaging (CT or MRI) unless onlybiopsy performed (in which case post-operative imaging is not routinely obtained. Inthese patients, the preoperative study will serve as baseline.

  • Patient should have surgery (biopsy, partial resection or gross total resection) andno additional anti-cancer therapy except the chemoradiation as specified in theprotocol.

  • For those patients in which steroids are clinically indicated, there must be a stableor decreasing dose of steroid medication for ≥ one week prior to the start ofinfusion.

  • 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 andwillingness to sign a written informed consent document.

  • Patient agrees to use an effective method of contraception (hormonal or two barriermethods) while on study and for at least 3 months following the Plerixafor infusion

Exclusion

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 anginaor arrhythmia

  • Prior malignancy except previously diagnosed and definitively treated more than 3years prior to trial or whose prognosis is deemed good enough to not warrantsurveillance

  • Prior sensitivity to Plerixafor

  • Pregnant or patients who are breastfeeding

Study Design

Total Participants: 30
Study Start date:
November 01, 2014
Estimated Completion Date:
September 30, 2018

Study 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.

Connect with a study center

  • Stanford University, School of Medicine

    Stanford, California 94305
    United States

    Site Not Available

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