Whole Brain Radiation Therapy With Standard Temozolomide Chemo-Radiotherapy and Plerixafor in Treating Patients With Glioblastoma

• Status: Recruiting
• Trial end date: 2027-01-11
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawrence D Recht; Stanford University
• Collaborator: Sanofi
• Treatments: Dacarbazine; JM 3100; Plerixafor; Temozolomide

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.