PPX, Temozolomide, and Concurrent Radiation for Newly Diagnosed Brain Tumors
Condition: Brain Tumor
MeSH terms: Brain Neoplasms
Intervention: PPX +TMZ+XRT
Intervention description: PPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: glioblastoma multiforme or anaplastic glioma

Summary:

      The purpose of this study is to determine the antitumor activity of PPX in combination with
      temozolomide and radiation for patients with newly diagnosed brain tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histopathologically confirmed, newly diagnosed, glioblastoma
             multiforme or anaplastic glioma (anaplastic astrocytoma [AA], anaplastic
             oligodendroglioma, and anaplastic oligoastrocytoma) and have not had a complete
             surgical resection.

          -  Patients must be 18 years of age or older.

          -  Patients must have a Zubrod performance status 0-2.

          -  Patients must not be on enzyme-inducing anti-epileptic drugs (EIAED). Patients may be
             on non-enzyme inducing anti-epileptic drugs (NEIAED) or may not be taking any
             anti-epileptic drugs.

          -  Patients must not have received prior chemotherapy, radiation or any experimental
             therapy for their glioblastoma.

          -  Patients may not be breast-feeding a child.

          -  Female patients must either be not of child bearing potential or have a negative
             pregnancy test within 14 days of starting study treatment. Patients are considered not
             of child bearing potential if they are surgically sterile (they have undergone a
             hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are
             postmenopausal. Pregnant or lactating females are not eligible. Should a woman become
             pregnant or suspect she is pregnant while participating in this study, she should
             inform her treating physician immediately.

          -  Female patients must be using an acceptable method of contraception (oral
             contraceptives, barrier methods, approved contraceptive implant, long-term injectable
             contraception, intrauterine device or tubal ligation) OR female patients must be at
             least 1-year post-menopausal or surgically sterile during their participation in this
             study (from the time they sign the consent form) to prevent pregnancy. Male patients
             must be surgically sterile or using an acceptable method of contraception during their
             participation in this study (from the time they sign the consent form) to prevent
             pregnancy in a partner

          -  Patients must have no concurrent malignancy except curatively treated basal or
             squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast.
             Patients with prior malignancies must be disease-free for ≥ 2 years.

          -  Patients must have normal organ and marrow function as defined below:

               -  Absolute neutrophil count > 1,500/ul

               -  Platelets > 100,000/ul

               -  Hemoglobin > 8 gm/dL

               -  Total bilirubin < 1.5 x ULN

               -  Creatinine < 1.5 x ULN

          -  Patient must have the capacity to understand and the willingness to sign a written
             informed consent document.

          -  Patient must be able to tolerate MRIs. CT scans can NOT be substituted for MRI in this
             study.

        Exclusion Criteria:

          -  Recurrent malignant gliomas.

          -  Tumor foci detected below the tentorium or beyond the cranial vault.

          -  Allergy to gadolinium or contraindication to MRI scan.

          -  Patients who have received any form of brachytherapy or radiosurgery for their
             glioblastoma prior to start of standard radiation.

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to PPX.

          -  Uncontrolled intercurrent illness including, but not limited to, hypertension ongoing
             or active infection, symptomatic congestive heart failure, unstable angina pectoris,
             cardiac arrhythmia, or psychiatric illness/social situations that would limit
             compliance with study requirements.

          -  Pregnant women are excluded from this study. Because there is an unknown but potential
             risk for adverse events in nursing infants secondary to treatment of the mother with
             PPX, breastfeeding should be discontinued if the mother is treated with PPX.