Vitamin D for Treatment of Glioblastoma Multiforme

NCT01181193 | Unknown Phase 1

• 1 other identifier: SOR504110CTIL
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is non-randomized phase 2 study to assess efficacy and toxicity of long term high dose vitamin D3 given concurrently with chemo-radiotherapy (CCRT) containing temozolomide followed by adjuvant chemotherapy (ACT) with temozolomide in patients with newly diagnosed glioblastoma multiforme GBM). Preoperative diagnosis of GBM will be based on magnetic resonance imaging (MRI) brain scan. All patient will underwent craniotomy with partial or total resection of a visible tumour mass. All patients will be planned for postoperative three-dimensional conformal RT (3-DCRT) or intensity-modulated RT (IMRT) to residual tumour and/or resection bed. A total RT dose of 54-60 Gy will be delivered using 2 Gy daily fractions given over 5 days a week. Daily chemotherapy with temozolomide in the dose of 75 mg/m2/day will be started at the first day of RT, and will be continued for entire period of RT inclusive week-end breaks. ACT will contain 6 cycles of oral temozolomide 150-200 mg/m2/day given for 5 days every 4 weeks. Oral vitamin D3 will be administered in daily dose of 4000 IU. Vitamin D3 therapy will be started 1 week prior to commencing CCRT, and will be terminated immediately after completing last cycle of ACT. MRI scan of the brain will be performed at 4 months after completing CCRT, and than will be repeated every 4 months for first 2 years, and every 6 months for subsequent years. The study participants will be followed until disease progression or death. The study is expected to complete within 4 years.

Conditions

Glioblastoma Multiforme

Keywords

glioblastoma multiforme; chemoradiotherapy; vitamin D

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  long term

Secondary Outcomes (1)

• Overall survival

  long term

Interventions

Surgery OTHER

Craniotomy with total or partial removal of the brain tumor

Radiotherapy to tumour bed and/or residual tumour RADIATION

60 Gy in 30 fractions over 6 weeks

Temozolomide DRUG

1. 75 mg/m2/day for entire period of radiotherapy 2. 150-200 mg/m2/day for 5 days every 28 days, 6 cycles total

Vitamin D3 DRUG

4000 IU started 1 week before commencing radiotherapy and discontinued immediately after completing last chemotherapy cycle

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Newly-diagnosed, histologically confirmed GBM
• Surgical procedures: craniotomy with gross tumour resection or maximal debulking
• Brain lesion suitable suitable for radical 3-DCRT/IMRT according to tumour location and size.
• Karnofsky performance status (KPS) \> 70 (ECOG/WHO 0-1)
• No previous RT to brain
• No serious comorbid condition
• No treatment with biological response modifiers or cytotoxic agents within four weeks prior to study entry
• No participation in clinical trial using any investigational drug or device within four weeks prior to study entry
• No serious complication of malignant condition
• No previous or concurrent malignancy at other sites, except cone biopsied in situ carcinoma of the uterine cervix and adequately treated basal cell or squamous cell carcinoma of the skin
• Adequate organ function as evidenced by the following peripheral blood counts or serum chemistries at study entry:
• Hemoglobin \> 9.0 Gm/dL
• WBC count \> 4.0x109/L
• Neutrophile count \> 1.5 cells x 109/L,

You may not qualify if:

• Surgical procedures: only stereotactic biopsy
• Brain lesion not suitable for 3-DCRT/IMRT
• KPS \< 70 (ECOG/WHO \<2)
• Previous RT to brain
• Treatment with biological response modifiers or cytotoxic agents within four weeks prior to study entry
• Participation in clinical trial using any investigational drug or device within 7 weeks prior to study entry
• Major surgical procedure within two weeks prior to study entry
• Serious comorbid condition, inclusive but not limited to myocardial infarction within previous six months, uncontrolled cardiac arrhythmias, uncontrolled angina pectoris, active infection including acute hepatitis
• Serious complication of malignant condition
• Previous or concurrent malignancy
• Known hypersensitivity to vitamin D
• Inadequate organ function as evidenced by the following peripheral blood counts or serum chemistries at study entry:
• Hemoglobin \< 9.0 Gm/dL
• WBC count \< 4.0x109/L
• Neutrophile count \< 1.5 cells x 109/L,

Sponsors & Collaborators

• Soroka University Medical Center: lead

Study Sites (1)

Soroka University Medical Center

Beersheba, 84101, Israel

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Interventions

Surgical Procedures, Operative; Temozolomide; Cholecalciferol

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Konstantin Lavrenkov, MD, PhD

  Soroka University Miedical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Konstantin Lavrenkov, MD, PhD

CONTACT

+97286400537; constant@bgu.ac.il

Olga Belochitski, MD

CONTACT

+97286400537; olgab@clalit.org.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 18, 2010
• First Posted: August 13, 2010
• Study Start: March 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2014
• Last Updated: March 29, 2011

Record last verified: 2010-08

Locations

IL (1)