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Complete title: PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation: A Randomized Phase II Study: BrUOG 244
|Research Study Number||7591|
|Principal Investigator||Maciej Mrugala, MD, PhD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
- Genders Eligible for Study: Both
- 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.
- KPS >60.
- Age > 18
- Life expectancy of at least 3 months.
- Absolute neutrophil count > 1500/mm3, Platelets > 100,000/mm,
- Creatinine < 2 x ULN
- 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.
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- 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)
Other exclusion criteria may apply.
Astrocytomas; Brain Cancer; Central Nervous System (CNS); Glioblastoma Multiforme; Solid Tumors
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