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Keep this study
Lead
Brown University
With
Rhode Island Hospital
Milton S. Hershey Medical Center
University of Washington
University of Massachusetts, Worcester
MaineHealth
University of California, San Diego
Thomas Jefferson University
To evaluate the toxicities of PPX/RT To evaluate neuro-cognitive functional assessments of patients with GBM receiving PPX/RT To obtain preliminary data in a randomized phase II study whether PPX/RT improves overall survival as compared to temozolomide /RT for patients with GBM without MGMT methylation to facilitate planning a phase III study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically proven diagnosis of glioblastoma or gliosarcoma (WHO grade IV)
GBM must have unmethylated MGMT as determined by central laboratory
Diagnosis of GBM must be made by biopsy or surgical excision, either partial or complete; as long as there is sufficient tissue to determine MGMT status
No prior chemotherapy or radiation for brain tumor
Must be able to tolerate brain MRIs.
\*A diagnostic contrast-enhanced MRI must be performed postoperatively within 42 days prior to study registration.
ALT or AST \< 3 x upper limit of normal (ULN) and total bilirubin \< 1.5x ULN.
Patients with a prior history of low grade glioma who did not receive prior radiation or chemotherapy with transformation to grade IV brain tumor are eligible.
Women must be non-lactating, and surgically sterile, post-menopausal or have a negative serum pregnancy test and agree to use adequate birth control. Males must agree to use adequate birth control.
Voluntary, signed informed consent.
You may not be if
Acute infection or other medical condition that would impair study treatment
No other active invasive malignancy unless disease free for at least 3 years.
Prior temozolomide or PPX.
Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted.
Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields.
No diffuse leptomeningeal disease, or gliomatosis cerebri.
Use of any other experimental chemotherapy drug within the 60 days prior to randomization and during the trial. (Use of a non-chemotherapy investigational agent must be approved by the Brown University Oncology Group)
Clareo Health | PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation
