Clinical Trial Details
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NCT01977677 : Plerixafor After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed High Grade Glioma
PhasePhase 1/Phase 2
AgesMin: 18 Years Max: 75 Years
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

- 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

- 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

- Prior sensitivity to Plerixafor

- Pregnant or patients who are breastfeeding
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