Vitamin D for Treatment of Glioblastoma Multiforme
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ClinicalTrials.gov Identifier: NCT01181193 |
Recruitment Status : Unknown
Verified August 2010 by Soroka University Medical Center.
Recruitment status was: Recruiting
First Posted : August 13, 2010
Last Update Posted : March 29, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Glioblastoma Multiforme | Other: Surgery Radiation: Radiotherapy to tumour bed and/or residual tumour Drug: Temozolomide Drug: Vitamin D3 | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | High-Dose Vitamin D in Combination With Chemoradiotherapy in the Treatment of Glioblastoma Multiforme |
Study Start Date : | March 2011 |
Estimated Primary Completion Date : | March 2013 |
Estimated Study Completion Date : | March 2014 |

- Other: Surgery
Craniotomy with total or partial removal of the brain tumor
- Radiation: Radiotherapy to tumour bed and/or residual tumour
60 Gy in 30 fractions over 6 weeks
- Drug: Temozolomide
- 75 mg/m2/day for entire period of radiotherapy
- 150-200 mg/m2/day for 5 days every 28 days, 6 cycles total
- Drug: Vitamin D3
4000 IU started 1 week before commencing radiotherapy and discontinued immediately after completing last chemotherapy cycle
- Progression free survival [ Time Frame: long term ]
- Overall survival [ Time Frame: long term ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
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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,
- Platelet count > 100 x 109/L,
- Creatinine < 1.5 mg/dL
- Total bilirubin < ULN (upper limit of normal)
- AST/SGOT < ULN
- Calcium < ULN
- Ability to sign informed consent
- Ability to attend follow-up visits
Exclusion Criteria:
- 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,
- Platelet count < 100 x 109/L,
- Creatinine > 1.5 mg/dL
- Total bilirubin > ULN (upper limit of normal)
- AST/SGOT > ULN
- Calcium > ULN
- Inability to sign informed consent
- Psychological, familial, sociological or geographical conditions which do not permit regular medical follow-up and compliance with the protocol.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01181193
Contact: Konstantin Lavrenkov, MD, PhD | +97286400537 | constant@bgu.ac.il | |
Contact: Olga Belochitski, MD | +97286400537 | olgab@clalit.org.il |
Israel | |
Soroka University Medical Center | Recruiting |
Beer Sheva, Israel, 84101 | |
Contact: Konstantin Lavrenkov, MD, PhD +97286400537 constant@bgu.ac.il | |
Contact: Olga Belochitski, MD +97286400537 olgab@clalit.org.il | |
Sub-Investigator: Vladimir Gavrilov, MD, PhD | |
Sub-Investigator: Olga Belochitski, MD | |
Sub-Investigator: Vladimir Merkin, MD |
Principal Investigator: | Konstantin Lavrenkov, MD, PhD | Soroka University Miedical Center |
Responsible Party: | Konstantin Lavrenkov, MD, PhD, Soroka University Medical Center |
ClinicalTrials.gov Identifier: | NCT01181193 |
Other Study ID Numbers: |
SOR504110CTIL |
First Posted: | August 13, 2010 Key Record Dates |
Last Update Posted: | March 29, 2011 |
Last Verified: | August 2010 |
glioblastoma multiforme chemoradiotherapy vitamin D |
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Vitamin D Cholecalciferol |
Temozolomide Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Calcium-Regulating Hormones and Agents |