Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase II Randomized Evaluation of 5-Lipoxygenase Inhibition by Herbal Complementary and Alternative Medicine Approach Compared to Control as an Adjuvant Therapy in Newly Diagnosed and Recurrent High-grade Gliomas
Verified date | April 2019 |
Source | Case Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 12 |
Est. completion date | March 2011 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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=75,000/mm^3); in the event of plate count dropping below 50,000/ mm^3 the Boswellia will be withdrawn until plate count reaches 75,000 mm^3 and above - Liver function (bilirubin and alkaline phosphatase =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 |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Ali Altunkaya | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Food Intake as Assessed by the Block 98 Food Frequency Questionnaire and a 3-day Food Record | The 3-day food diary will be used to assess the dietary intake and to increase eating awareness of patients. | At 2, 4, 6, 12, and 24 months | |
Primary | Change From Pooled Baseline in Peritumoral Brain Edema | The relative change from baseline will be assessed longitudinally, however, the main comparison of interest is the relative change at the 4-month evaluation. For each patient change = edema at follow up - baseline edema | at 2 months | |
Primary | Change From Baseline in Peritumoral Brain Edema | The relative change from baseline will be assessed longitudinally, however, the main comparison of interest is the relative change at the 4-month evaluation.For each patient change = edema at follow up - baseline edema. | at 4 months | |
Primary | Change From Baseline in Peritumoral Brain Edema | The relative change from baseline will be assessed longitudinally, however, the main comparison of interest is the relative change at the 4-month evaluation. For each patient change = edema at follow up - baseline edema. | at 6 months | |
Secondary | Quality of Life at 6 Months | Quality of life as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Items (EORTC QLQ-C30) | At 2, 4, 6, 12, and 24 months | |
Secondary | Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 6 Months | Percentage of participants with tumor progression (>25% increase in tumor volume compared to time 0) will be measured from enrollment to documented progression or death whichever comes first. The method used to calculate the time to tumor progression was Kaplan Meier test method to define the 95% confidence levels. | 6 months | |
Secondary | Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 1 Year | Percentage of participants with tumor progression (>25% increase in tumor volume compared to time 0) will be measured from enrollment to documented progression or death whichever comes first. The method used to calculate the time to tumor progression was Kaplan Meier test method to define the 95% confidence levels. | 1 year | |
Secondary | Overall Survival: Percentage of Patients That Were Alive at 1 Year | Overall survival will be measured from the date of enrollment to date of death or last contact. Survival will be evaluated by the Kaplan Meier method to evaluate the median survival and 1 year survival rates. | 1 year. |
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