Boswellia serrata and Standard Treatment or Standard Treatment Alone in Treating Patients Who Have Undergone Surgery and Radiation Therapy for Newly Diagnosed or Recurrent High-Grade Glioma
|Phase II||Treatment||Active||18 and over||NCI||CASE-CCF-7348|
CCF-7348, NCT00243022, CASE1304200
Special Category: NCI Web site featured trial
- Compare the efficacy of addition of adjuvant Boswellia serrata, a selective anti-inflammatory herbal medicine, to standard treatment vs standard treatment alone in reducing tumor growth and peritumoral brain edema in patients with newly diagnosed or recurrent high-grade gliomas.
- Compare the progression-free and overall survival of patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
- Compare the use of steroids between the two groups.
- Histologically confirmed high-grade glioma of 1 of the following types:
- Grade III astrocytoma (anaplastic astrocytoma)
- Grade IV astrocytoma (glioblastoma multiforme)
- Anaplastic oligodendroglioma
- Newly diagnosed or recurrent disease
- Had undergone prior surgical resection followed by post-surgical radiotherapy
- Concurrent standard or investigational immunotherapy or biologic agents as primary treatment for brain tumor allowed
- Concurrent standard or investigational chemotherapy as primary treatment for brain tumor allowed
- Concurrent glucocorticoid therapy allowed
- Concurrent standard or investigational hormonal therapy as primary treatment for brain tumor allowed
- See Disease Characteristics
- See Disease Characteristics
- No other concurrent herbal preparations containing 5-lipoxygenase inhibitors, including any of the following:
- Boswellia serrata
- H 15 Ayurmedica sallaki
- Boswellia extract
- Boswellia resin extract
- Ayur-Boswellia serrata
- Boswellia extract
- Boswellia serrata standardized extract
- Boswellia with ascorbic acid (vitamin C)
- Cyclooxygenase-2 (COX-2) combo
- COX-2-IH plus
- Methylsulfonylmethane (MSM) with Boswellia
- Hypericum perforatum (St. John's wort)
- Karnofsky 70-100%
- Not specified
- Absolute neutrophil count ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
- Bilirubin ≤ 2 times normal
- Alkaline phosphatase ≤ 2 times normal
- SGOT ≤ 3 times normal
- No liver disease
- BUN ≤ 1.5 times normal
- Creatinine ≤ 1.5 times normal
- No kidney disease
- No asthma
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No medical condition that would interfere with eating and oral administration of study drug
- No active infection
- No other malignancy within the past 3 years except surgically cured carcinoma in situ of the cervix or nonmelanoma skin cancer
A total of 70 patients (35 per treatment arm) will be accrued for this study.
Efficacy of a selective anti-inflammatory herbal regimen in reducing peritumoral brain edema at 6 months
Quality of life at 6 months
Progression-free survival at 6 months
Overall survival at 6 months
This a randomized, controlled study. Patients are stratified according to age (< 65 years vs > 65 years) and Karnofsky performance status (70-80% vs 90-100%). Patients are randomized to 1 of 2 treatment arms.
- Arm I (intervention): Patients receive oral Boswellia serrata herbal extract 4 times a day and oral cyanocobalamin (vitamin B12) once a day for 6 months in the absence of unacceptable toxicity.
- Arm II (control): Patients receive oral vitamin B12 once a day for 6 months.
All patients are encouraged to eat a regular balanced diet (as recommended by the American Cancer Society for cancer prevention) with limited consumption of red and processed meats.
Quality of life will be assessed at baseline and then at 2, 4, 6, 12, and 24 months.
After completion of study treatment, patients will be followed every 6 months.
Trial Lead Organizations
Cleveland Clinic Taussig Cancer Center
|Glen Stevens, DO, PhD, Protocol chair|
|Cleveland Clinic Taussig Cancer Center|
|Clinical Trials Office - Cleveland Clinic Taussig Cancer Center|
|Official Title||Phase II Randomized Evaluation of 5-Lipoxygenase Inhibition by Boswellia serrata Herbal Medicine Approach Compared to Control as an Adjuvant Therapy in Newly Diagnosed and Recurrent High-grade Gliomas|
|Trial Start Date||2005-08-18|
|Trial Completion Date||2009-09-09 (estimated)|
|Registered in ClinicalTrials.gov||NCT00243022|
|Date Submitted to PDQ||2005-08-19|
|Information Last Verified||2008-10-22|
|NCI Grant/Contract Number||CA107277, CA43703|
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.