PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Brown University
• Collaborators: Maine Medical Center; MaineHealth; Milton S. Hershey Medical Center; Rhode Island Hospital; Thomas Jefferson University; University of California, San Diego; University of Massachusetts, Worcester; University of Washington
• Treatments: Dacarbazine; Paclitaxel poliglumex; Temozolomide

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)