Secondary

1. Compare the progression-free and overall survival of patients treated with these regimens.
2. Compare the quality of life of patients treated with these regimens.
3. 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

• Karnofsky 70-100%

Life expectancy

• Not specified

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

• No asthma

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

A total of 70 patients (35 per treatment arm) will be accrued for this study.

Outcomes

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

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

U.S.A.
Ohio
	Cleveland
	Cleveland Clinic Taussig Cancer Center
		Clinical Trials Office - Cleveland Clinic Taussig Cancer Center	Ph:  866-223-8100

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		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

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