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Whole Brain Radiation Therapy With Standard Temozolomide Chemo-Radiotherapy and Plerixafor in Treating Patients With Glioblastoma
Not Recruiting
Trial ID: NCT03746080
Purpose
This phase II trial studies how well whole brain radiation therapy works with standard
temozolomide chemo-radiotherapy and plerixafor in treating patients with glioblastoma (brain
tumor). Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.
Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth
of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping
them from spreading. Plerixafor is a drug that may prevent recurrence of glioblastoma after
radiation treatment. Giving whole brain radiation therapy with standard temozolomide
chemo-radiotherapy and plerixafor may work better in treating patients with glioblastoma.
Official Title
A Follow-Up Study to Add Whole Brain Radiotherapy (WBRT) to Standard Temozolomide Chemo-Radiotherapy in Newly Diagnosed Glioblastoma (GBM) Treated With 4 Weeks of Continuous Infusion Plerixafor
Stanford Investigator(s)
Eligibility
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.
Intervention(s):
drug: Plerixafor
drug: Temozolomide
radiation: Whole-Brain Radiotherapy (WBRT)
radiation: Radiation Therapy
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Hari Priya Yerraballa
650-724-9363