Status:
TERMINATED
Dietary, Herbal and Alternative Medicine in Glioblastoma Multiforme
Lead Sponsor:
Ali Altunkaya
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Cerebral Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 st...
Detailed Description
OBJECTIVES: Primary * To determine whether a herbal approach to decreasing 5-LO eicosanoid production reduces peritumoral brain edema in patients with HGG. Secondary * To determine if this adjuvan...
Eligibility Criteria
Inclusion
- 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=75,000/mm\^3); in the event of plate count dropping below 50,000/ mm\^3 the Boswellia will be withdrawn until plate count reaches 75,000 mm\^3 and above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study intervals of 4 and 6 months; if there is any significant deterioration in their condition the Boswellia will be withdrawn until these parameters are restored to their pre-treatment levels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
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00243022
Start Date
September 1 2004
End Date
March 1 2011
Last Update
April 30 2019
Active Locations (1)
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1
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195