PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation
Condition: Glioblastoma Multiforme
MeSH terms: Glioblastoma
Intervention: PPX (CT2103); Temozolomide
Intervention description: XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum.; XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum
Intervention MeSH terms: Temozolomide; Paclitaxel poliglumex
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Brain Tumors; Glioblastoma Multiforme; GBM

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.
    

Eligibility 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)