Vitamin D for Treatment of Glioblastoma Multiforme

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Soroka University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT01181193
First received: July 18, 2010
Last updated: March 27, 2011
Last verified: August 2010
  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.


Condition Intervention 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
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High-Dose Vitamin D in Combination With Chemoradiotherapy in the Treatment of Glioblastoma Multiforme

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: long term ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: long term ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: March 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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
    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
    Drug: Vitamin D3
    4000 IU started 1 week before commencing radiotherapy and discontinued immediately after completing last chemotherapy cycle
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01181193

Contacts
Contact: Konstantin Lavrenkov, MD, PhD +97286400537 constant@bgu.ac.il
Contact: Olga Belochitski, MD +97286400537 olgab@clalit.org.il

Locations
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         
Sponsors and Collaborators
Soroka University Medical Center
Investigators
Principal Investigator: Konstantin Lavrenkov, MD, PhD Soroka University Miedical Center
  More Information

No publications provided

Responsible Party: Konstantin Lavrenkov, MD, PhD, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT01181193     History of Changes
Other Study ID Numbers: SOR504110CTIL
Study First Received: July 18, 2010
Last Updated: March 27, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Soroka University Medical Center:
glioblastoma multiforme
chemoradiotherapy
vitamin D

Additional relevant MeSH terms:
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
Ergocalciferols
Vitamins
Temozolomide
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014