Dietary, Herbal and Alternative Medicine in Glioblastoma Multiforme

• Status: Terminated
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ali Altunkaya
• Collaborator: National Cancer Institute (NCI)
• Treatments: Hydroxocobalamin; Vitamin B 12; Vitamin B Complex; Vitamins

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=75,000/mm^3); in the event of plate count dropping below 50,000/ mm^3 the Boswellia will be withdrawn until plate count reaches 75,000 mm^3 and above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