Dietary, Herbal and Alternative Medicine in Glioblastoma Multiforme

NCT00243022 | Terminated Phase 2 Results DMC

• 4 other identifiers: CASE1304CCF-7348NCI-2010-01384R21CA107277-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain and Central Nervous System Tumors; Cerebral Edema

Keywords

cerebral edema; adult glioblastoma; adult giant cell glioblastoma; adult gliosarcoma; adult anaplastic astrocytoma; adult anaplastic oligodendroglioma

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (4)

• Quality of Life at 6 Months

  At 2, 4, 6, 12, and 24 months

• Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 6 Months

  6 months

• Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 1 Year

  1 year

• Overall Survival: Percentage of Patients That Were Alive at 1 Year

  1 year.

Other Outcomes (1)

• Food Intake as Assessed by the Block 98 Food Frequency Questionnaire and a 3-day Food Record

  At 2, 4, 6, 12, and 24 months

Study Arms (2)

Arm I (intervention)

EXPERIMENTAL

Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.

Drug: Boswellia serrata extract; Dietary Supplement: cyanocobalamin

Arm II (control)

ACTIVE COMPARATOR

Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.

Dietary Supplement: cyanocobalamin

Interventions

Boswellia serrata extract DRUG

given orally

Arm I (intervention)

cyanocobalamin DIETARY_SUPPLEMENT

given orally

Also known as: Vitamin B12

Arm I (intervention); Arm II (control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ali Altunkaya: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Brain Edema; Glioblastoma; Gliosarcoma; Astrocytoma; Oligodendroglioma

Interventions

Frankincense; Vitamin B 12

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Resins, Plant; Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Limitations and Caveats

Certain outcome analysis not done due to low patient accrual.

Results Point of Contact

• Title: Dr. Glen Stevens
• Organization: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

steveng@ccf.org

Study Officials

• Glen Stevens, DO, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 20, 2005
• First Posted: October 21, 2005
• Study Start: September 1, 2004
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2011
• Last Updated: April 30, 2019
• Results First Posted: July 30, 2013

Record last verified: 2019-04

Locations

US (1)