Phase II Randomized Study of Adjuvant Boswellia serrata and Standard Treatment Versus Standard Treatment Alone in Patients With Newly Diagnosed or Recurrent High-Grade Gliomas
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Related Information Registry Information
Alternate Title
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
Basic Trial Information
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Protocol IDs
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Phase II
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Treatment
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Active
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18 and over
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NCI
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CASE-CCF-7348 CCF-7348, NCT00243022, CASE1304200
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Special Category:
NCI Web site featured trial Objectives Primary - 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.
Secondary - 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.
Entry Criteria Disease Characteristics:
- Histologically confirmed high-grade glioma of 1 of the following types:
- Grade III astrocytoma (anaplastic astrocytoma)
- Grade IV astrocytoma (glioblastoma multiforme)
- Anaplastic oligodendroglioma
- Oligoastrocytoma
- Newly diagnosed or recurrent disease
- Had undergone prior surgical resection followed by post-surgical radiotherapy
Prior/Concurrent Therapy:
Biologic therapy - Concurrent standard or investigational immunotherapy or biologic agents as primary treatment for brain tumor allowed
Chemotherapy - Concurrent standard or investigational chemotherapy as primary treatment for brain tumor allowed
Endocrine therapy - Concurrent glucocorticoid therapy allowed
- Concurrent standard or investigational hormonal therapy as primary treatment for brain tumor allowed
Radiotherapy - See Disease Characteristics
Surgery - See Disease Characteristics
Other - No other concurrent herbal preparations containing 5-lipoxygenase inhibitors, including any of the following:
- Boswellia serrata
- H 15 Ayurmedica sallaki
- Boswellia extract
- Boswellin
- Boswellia resin extract
- Ayur-Boswellia serrata
- Boswellia extract
- Boswellia
- Boswellia serrata standardized extract
- Weihrauch
- Boswellia with ascorbic acid (vitamin C)
- Cyclooxygenase-2 (COX-2) combo
- COX-2-IH plus
- Methylsulfonylmethane (MSM) with Boswellia
- MSM
- BotanoDyne
- Melatonin
- Hypericum perforatum (St. John's wort)
- Curcumin
Patient Characteristics:
Performance status Life expectancy Hematopoietic - Absolute neutrophil count ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
Hepatic - Bilirubin ≤ 2 times normal
- Alkaline phosphatase ≤ 2 times normal
- SGOT ≤ 3 times normal
- No liver disease
Renal - BUN ≤ 1.5 times normal
- Creatinine ≤ 1.5 times normal
- No kidney disease
Pulmonary Other - 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
Expected Enrollment 70A total of 70 patients (35 per treatment arm) will be accrued for this study. Outcomes Primary Outcome(s)Efficacy of a selective anti-inflammatory herbal regimen in reducing peritumoral brain edema at 6 months
Secondary Outcome(s)Quality of life at 6 months Progression-free survival at 6 months Overall survival at 6 months
Outline 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 Contact Information
Trial Lead Organizations Cleveland Clinic Taussig Cancer Center | | | Glen Stevens, DO, PhD, Protocol chair | | Ph: 216-445-1787; 800-862-7798 |
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U.S.A. |
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Cleveland |
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| | | | | | | | Cleveland Clinic Taussig Cancer Center |
| | Clinical Trials Office - Cleveland Clinic Taussig Cancer Center | |
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Related Information Featured trial article
Registry Information | | 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 | | 2008-09-09 (estimated) | | Registered in ClinicalTrials.gov | | NCT00243022 | | Date Submitted to PDQ | | 2005-08-19 | | Information Last Verified | | 2008-09-26 | | 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. Back to Top |