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Vitamin D for Treatment of Glioblastoma Multiforme

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age > 18 years. 2. Newly-diagnosed, histologically confirmed GBM. 3. Surgical procedures: craniotomy with gross tumour resection or maximal debulking. 4. Brain lesion suitable suitable for radical 3-DCRT/IMRT according to tumour location and size. 5. Karnofsky performance status (KPS) > 70 (ECOG/WHO 0-1) 6. No previous RT to brain. 7. No serious comorbid condition. 8. No treatment with biological response modifiers or cytotoxic agents within four weeks prior to study entry. 9. No participation in clinical trial using any investigational drug or device within four weeks prior to study entry. 10. No serious complication of malignant condition. 11. 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. 12. 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.
13. Ability to sign informed consent. 14. Ability to attend follow-up visits.

Exclusion Criteria:

1. Surgical procedures: only stereotactic biopsy. 2. Brain lesion not suitable for 3-DCRT/IMRT. 3. KPS < 70 (ECOG/WHO <2) 4. Previous RT to brain. 5. Treatment with biological response modifiers or cytotoxic agents within four weeks prior to study entry. 6. Participation in clinical trial using any investigational drug or device within 7 weeks prior to study entry. 7. Major surgical procedure within two weeks prior to study entry. 8. 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. 9. Serious complication of malignant condition. 10. Previous or concurrent malignancy. 11. Known hypersensitivity to vitamin D. 12. 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.
13. Inability to sign informed consent. 14. Psychological, familial, sociological or geographical conditions which do not permit regular medical follow-up and compliance with the protocol.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01181193
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Soroka University Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Konstantin Lavrenkov, MD, PhD
Principal Investigator Affiliation Soroka University Miedical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Unknown status
Countries Israel
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma Multiforme

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Soroka University Medical Center, Beer Sheva, Israel

Status

Recruiting

Address

Soroka University Medical Center

Beer Sheva, , 84101

Site Contact

Konstantin Lavrenkov, MD, PhD

[email protected]

+97286400537

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