A Study of High-Dose Chemoradiation Using Biologically-Based Target Volume Definition in Patients With Glioblastoma
Condition: Glioma
MeSH terms: Glioblastoma
Intervention: High Dose Radiation; Temozolomide
Intervention description: Radiation will be delivered once daily for a total of 30 fractions, five days per week.; Patients will receive concurrent temozolomide (75 mg/m^2 daily for 6 weeks). Adjuvant temozolomide will be given at 150-200 mg/m^2, D1-5 every 28 days for a minimum of six cycles and will be started approximately four weeks following completion of radiotherapy.
Intervention MeSH terms: Temozolomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a study to determine the safety and effectiveness of high-dose radiation therapy (RT)
      with concurrent temozolomide in patients with newly diagnosed glioblastoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newly diagnosed histologically-confirmed supratentorial World Health Organization
             (WHO) grade IV gliomas including glioblastoma multiforme and gliosarcoma

          -  Age 18 or older

          -  Karnofsky performance status (a measure to quantify general well being and activities
             of daily life; scale ranges from 0 to 100 where 100 is perfect health) of greater than
             or equal to 70

          -  Life expectancy of at least 12 weeks

          -  Adequate bone marrow reserve (hemoglobin greater than or equal to 10, absolute
             neutrophil count greater than or equal to 1500, platelets greater than or equal to
             100,000); acceptable liver function (total bilirubin less than or equal to 2.0 mg/dl,
             ALT (Alanine Aminotransferase)/AST (Aspartate Aminotransferase) less than or equal to
             5 times the normal range); acceptable renal function (serum creatinine less than or
             equal to 2.0 mg/dl). Eligibility level for hemoglobin may be reached by transfusion.

          -  Maximal contiguous volume of tumor based on high b-value diffusion MRI < 1/3 volume of
             brain

          -  Patients must be registered within 6 weeks of most recent resection.

          -  Patients must have signed a study-specific informed consent.

        Exclusion Criteria:

          -  Recurrent glioma, or tumor involving the brainstem or cerebellum. Prior low-grade
             glioma without prior RT, now with malignant progression are eligible.

          -  Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment is
             not permitted. Prior chemotherapy for a different cancer is allowable, except for
             Temozolomide or Bevacizumab.

          -  Evidence of cerebrospinal fluid dissemination (positive cerebrospinal fluid cytology
             for malignancy or MRI findings consistent with CSF dissemination)

          -  Evidence of severe concurrent disease requiring treatment

          -  Prior invasive malignancy (except non-melanoma skin cancer) unless disease-free for a
             minimum of 3 years (for example, carcinoma in situ of breast, oral cavity or cervix
             are all permissible)

          -  Patients unable to undergo Magnetic Resonance Imaging exams (MRI) (i.e. patients with
             non-compatible devices such as cardiac pacemakers, other implanted electronic devices,
             metallic prostheses, or ferromagnetic prostheses (e.g. pins in artificial joints and
             surgical pins/clips) or unable to receive gadolinium for MRI, as per the standard UM
             Department of Radiology MRI screening criteria)

          -  Patients treated with previous cranial or head/neck radiotherapy leading to radiation
             field overlap

          -  Females of child-bearing potential must have a negative pregnancy test within 14 days
             prior to registration. Patients with reproductive potential must agree to use an
             effective contraceptive method during treatment.