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Vitamin D for Treatment of Glioblastoma Multiforme

Primary Purpose

Glioblastoma Multiforme

Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Surgery
Radiotherapy to tumour bed and/or residual tumour
Temozolomide
Vitamin D3
Sponsored by
Soroka University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma Multiforme focused on measuring glioblastoma multiforme, chemoradiotherapy, vitamin D

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Soroka University Medical CenterRecruiting

Outcomes

Primary Outcome Measures

Progression free survival

Secondary Outcome Measures

Overall survival

Full Information

First Posted
July 18, 2010
Last Updated
March 27, 2011
Sponsor
Soroka University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01181193
Brief Title
Vitamin D for Treatment of Glioblastoma Multiforme
Official Title
High-Dose Vitamin D in Combination With Chemoradiotherapy in the Treatment of Glioblastoma Multiforme
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
March 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Soroka University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma Multiforme
Keywords
glioblastoma multiforme, chemoradiotherapy, vitamin D

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Konstantin Lavrenkov, MD, PhD
Phone
+97286400537
Email
constant@bgu.ac.il
First Name & Middle Initial & Last Name or Official Title & Degree
Olga Belochitski, MD
Phone
+97286400537
Email
olgab@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konstantin Lavrenkov, MD, PhD
Organizational Affiliation
Soroka University Miedical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soroka University Medical Center
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konstantin Lavrenkov, MD, PhD
Phone
+97286400537
Email
constant@bgu.ac.il
First Name & Middle Initial & Last Name & Degree
Olga Belochitski, MD
Phone
+97286400537
Email
olgab@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Vladimir Gavrilov, MD, PhD
First Name & Middle Initial & Last Name & Degree
Olga Belochitski, MD
First Name & Middle Initial & Last Name & Degree
Vladimir Merkin, MD

12. IPD Sharing Statement

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Vitamin D for Treatment of Glioblastoma Multiforme

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