Clinical Trial Finder

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

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.

Arms

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

Undergo radiation therapy

Drug: - temozolomide

Given PO

Drug: - plerixafor

Given IV

Other: - laboratory biomarker analysis

Correlative studies

Other: - pharmacological study

Correlative studies