Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Vitamin D for Treatment of Glioblastoma Multiforme

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by:
Soroka University Medical Center

Tracking Information
First Submitted Date  ICMJE July 18, 2010
First Posted Date  ICMJE August 13, 2010
Last Update Posted Date March 29, 2011
Study Start Date  ICMJE March 2011
Estimated Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2010)
Progression free survival [ Time Frame: long term ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01181193 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2010)
Overall survival [ Time Frame: long term ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D for Treatment of Glioblastoma Multiforme
Official Title  ICMJE High-Dose Vitamin D in Combination With Chemoradiotherapy in the Treatment of Glioblastoma Multiforme
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma Multiforme
Intervention  ICMJE
  • 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
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 12, 2010)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2014
Estimated Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01181193
Other Study ID Numbers  ICMJE SOR504110CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Konstantin Lavrenkov, MD, PhD, Soroka University Medical Center
Study Sponsor  ICMJE Soroka University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Konstantin Lavrenkov, MD, PhD Soroka University Miedical Center
PRS Account Soroka University Medical Center
Verification Date August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP