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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Brain and Central Nervous System Tumors, Cerebral Edema

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Trial Information

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


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 adjuvant approach improves the quality of life and progression
free and overall survival of patients with HGG.

OUTLINE: This a randomized, controlled study. 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 B-12) once a day for 6 months in the absence of
unacceptable toxicity.

- Arm II (control): Patients receive oral vitamin B-12 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.

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

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change from baseline in peritumoral brain edema

Outcome Description:

The relative change from baseline will be assessed longitudinally, however, the main comparison of interest is the relative change at the 4-month evaluation.

Outcome Time Frame:

at 2 months

Safety Issue:

No

Principal Investigator

Glen Stevens, DO, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Food and Drug Administration

Study ID:

CASE1304

NCT ID:

NCT00243022

Start Date:

September 2004

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Cerebral Edema
  • cerebral edema
  • adult glioblastoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
  • Brain Edema
  • Edema
  • Glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterCleveland, Ohio  44195