Whole Brain Radiation Therapy With Standard Temozolomide Chemo-Radiotherapy and Plerixafor in Treating Patients With Glioblastoma
Glioblastoma, Glioblastoma With Primitive Neuronal Component, Gliosarcoma
About this trial
This is an interventional treatment trial for Glioblastoma
Eligibility Criteria
Inclusion Criteria:
- Patients must have tissue confirmation of high grade (World Health Organization (WHO) grade IV) glioma including but not limited to glioblastoma, gliosarcoma, glioblastoma with oligodendroglial features, glioblastoma with primitive neuroectodermal tumor (PNET) features.
- The patient must have post-operative contrast enhanced imaging (computed tomography [CT] or magnetic resonance imaging [MRI]) unless only biopsy performed. For patients having biopsy alone, post-operative imaging is not routinely obtained and therefore 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 chemo-radiation as specified in the protocol.
- Patients must have Karnofsky performance score >= 60.
- Absolute neutrophil count (ANC) >= 1500 (at time of screening).
- Platelets >= 100,000 ml (at time of screening).
- Serum creatinine =< 1.5mg/dl (at time of screening).
- Creatinine (Cr) clearance should be > 50 mL/min (at time of screening).
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 times the upper limit of normal (at time of screening).
- If female of childbearing potential, negative pregnancy test (at time of screening).
- 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.
- Prior malignancy except for non-melanoma skin cancer and carcinoma in situ (of the cervix or bladder), unless diagnosed and definitively treated more than 3 years prior to 1st dose of investigational drug.
- Prior sensitivity to plerixafor.
- Pregnant or patients who are breastfeeding.
Sites / Locations
- Stanford Cancer Institute Palo AltoRecruiting
Arms of the Study
Arm 1
Experimental
Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy
After completion maximal safe surgical resection, patients undergo radiation therapy for 42 days, initiating whole brain radiation therapy at day 21 (dose 16 of radiation therapy) and receive temozolomide daily on days 1 to 42. Beginning 7 days before the completion of whole brain radiation therapy, patients receive plerixafor by continuous infusion on days to 1 to 28. Beginning 1 week after completion of plerixafor infusion and 35 days after completion of whole brain radiation therapy, patients receive temozolomide monthly for 6 to 12 courses in the absence of disease progression or unacceptable toxicity.