Brain/Spinal Cord Cancers
|Recruiting||Astrocytomas; Brain Cancer; Central Nervous System (CNS); Glioblastoma Multiforme; Solid Tumors||Phase II||
To obtain preliminary data in a randomized phase II study whether PPX/RT improves progression-free survival as compared to temozolomide/RT for patients with GBM without MGMT methylation.
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.
- 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)
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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- Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.