Dietary, Herbal and Alternative Medicine in Glioblastoma Multiforme
Condition: Brain and Central Nervous System Tumors; Cerebral Edema
MeSH terms: Glioblastoma; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Edema
Intervention: Boswellia serrata extract; cyanocobalamin
Intervention description: given orally; given orally
Intervention MeSH terms: Vitamin B 12; Hydroxocobalamin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cerebral edema; adult glioblastoma; adult giant cell glioblastoma; adult gliosarcoma; adult anaplastic astrocytoma; adult anaplastic oligodendroglioma

Summary:

      RATIONALE: Giving the herb Boswellia serrata after surgery and radiation therapy may slow the
      growth of any remaining tumor cells. It is not yet known whether giving Boswellia serrata
      together with standard treatment is more effective than standard treatment alone in treating
      high-grade gliomas.

      PURPOSE: This randomized phase II trial is the study of a combination of complementary and
      alternative medicine (CAM) herbal supplement intervention as an adjuvant to standard
      treatment of patients with newly diagnosed and recurrent high-grade gliomas (HGG). The
      central hypothesis of this application is that a herbal preparation that inhibits 5-LO
      activity, will produce measurable biologically meaningful decrease in 5-LO eicosanoid
      production and brain edema that will be associated with improved survival and quality of life
      in patients with HGG.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  Patients after surgical removal of histologically confirmed World Health Organization
             high-grade gliomas, including astrocytomas grade III (anaplastic astrocytoma),
             astrocytoma grade IV (glioblastoma multiforme, GBM), anaplastic oligodendroglioma and
             oligoastrocytoma

          -  Karnofsky performance status of greater or equal 60

          -  Patients who signed informed consent

          -  Patients can be receiving standard or investigational chemotherapy , hormonal therapy,
             immunotherapy or biologic agents as the primary treatment for their tumor

          -  Glucocorticoid therapy is allowed

          -  Bone marrow function (absolute neutrophil count [ANC] >=1500/mm^3 and platelet count
             >=75,000/mm^3); in the event of plate count dropping below 50,000/ mm^3 the Boswellia
             will be withdrawn until plate count reaches 75,000 mm^3 and above

          -  Liver function (bilirubin and alkaline phosphatase =< 2 x normal and serum glutamic
             oxaloacetic transaminase [SGOT] =< 3 x normal)

          -  Renal function (blood urea nitrogen [BUN] or creatinine =< 1.5 x normal)

          -  Patients suffering from mild to moderate asthma, liver and kidney disease; an
             assessment of the condition will be made to establish a baseline and monitor progress
             at 4 weekly intervals to start with for the first two months and thereafter at the
             usual study intervals of 4 and 6 months; if there is any significant deterioration in
             their condition the Boswellia will be withdrawn until these parameters are restored to
             their pre-treatment levels

        EXCLUSION CRITERIA:

          -  Any medical condition that could interfere with eating and oral administration of B.
             serrata

          -  Patients already taking herbal preparations that contain 5-LO inhibitors

          -  Any previous (within the past 3 years) or concurrent malignancies at other sites, with
             the exception of surgically cured carcinoma-in-situ of the cervix and non-melanoma
             skin cancer

          -  Pregnancy and breastfeeding

          -  Active infection

          -  Inability to be followed closely at the Cleveland Clinic Foundation