Presurgery Bortezomib for Recurrent Malignant Gliomas Followed by Postop Bortezomib & Temozolomide
Condition: Brain and Central Nervous System Tumors
MeSH terms: Glioma; Nervous System Neoplasms; Central Nervous System Neoplasms
Intervention: Bortezomib; Temozolomide
Intervention description: Before surgery, an injection of bortezomib is given on days 1, 4, and 8. After surgery, bortezomib is given on days 7 and 21 of each cycle (1 cycle = 28 days).; After surgery, temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle (1 cycle = 28 days).
Intervention MeSH terms: Temozolomide; Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: brain tumor

Summary:

      Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell
      growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the
      growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving
      bortezomib before surgery may make the tumor smaller and reduce the amount of normal tissue
      that needs to be removed. Giving bortezomib together with temozolomide after surgery may kill
      any tumor cells that remain after surgery.

      This phase II trial is studying how well giving bortezomib before surgery followed by giving
      bortezomib together with temozolomide after surgery works in treating patients with recurrent
      malignant glioma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed malignant glioma, including any of the following subtypes:

               -  Glioblastoma multiforme

               -  Gliosarcoma

               -  Anaplastic astrocytoma

               -  Anaplastic oligodendroglioma

               -  Anaplastic mixed oligoastrocytoma

               -  Malignant astrocytoma not otherwise specified

          -  Must show unequivocal evidence of tumor recurrence or progression by MRI or CT scan
             with contrast

          -  Candidate for surgery AND requires surgery

               -  Evaluable or measurable disease following resection of recurrent tumor is not
                  required

          -  Failed prior standard radiotherapy and temozolomide

               -  Patients who have undergone stereotactic radiosurgery must have confirmation of
                  true progressive disease (rather than radiation necrosis) by PET scan, magnetic
                  resonance spectroscopy (MRS), or magnetic resonance perfusion (MRP) prior to
                  surgery

               -  Patients with lower-grade gliomas that have undergone radiographic malignant
                  transformation allowed provided they failed radiotherapy (with or without
                  temozolomide) and require surgery

          -  Life expectancy > 12 weeks

        Exclusion Criteria:

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  No other medical issues (e.g., bleeding, infection, HIV, or serious medical or
             psychiatric illness) that would preclude study therapy

          -  Myocardial infarction within the past 6 months

          -  No other active cancer(s) except non-melanoma skin cancer or carcinoma in situ of the
             cervix, unless in complete remission and off of all therapy for that cancer for ≥ 3
             years

          -  No hypersensitivity to bortezomib, boron, or mannitol

          -  More than 4 weeks since prior radiotherapy

          -  At least 4 weeks since prior cytotoxic therapy (6 weeks for nitrosoureas)

          -  At least 3 weeks since prior investigational drugs

          -  At least 2 weeks since prior enzyme-inducing anticonvulsants

          -  Concurrent non-enzyme-inducing anticonvulsants allowed

          -  No other concurrent standard or investigational anticancer treatment