Glioblastoma MultiformePhase 1/2NCT01181193
Vitamin D for Treatment of Glioblastoma Multiforme
A Phase 1/2 study testing Surgery, Radiotherapy to tumour bed and/or residual tumour and Temozolomide in people with Glioblastoma Multiforme, run by Soroka University Medical Center at 1 site in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- Surgery, Radiotherapy to tumour bed and/or residual tumour and Temozolomide
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2011to Mar 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Soroka University Medical Center
Beersheba, 84101
Konstantin Lavrenkov, MD, PhD, +97286400537, constant@bgu.ac.il
Olga Belochitski, MD, +97286400537, olgab@clalit.org.il
About this study
Official title: High-Dose Vitamin D in Combination With Chemoradiotherapy in the Treatment of Glioblastoma Multiforme
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.
- Conditions
- Glioblastoma Multiforme
- Being tested
- Surgery, Radiotherapy to tumour bed and/or residual tumour, Temozolomide, Vitamin D3
- Keywords
- glioblastoma multiforme, chemoradiotherapy, vitamin D
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryOther
Craniotomy with total or partial removal of the brain tumor
Radiotherapy to tumour bed and/or residual tumourRadiation
60 Gy in 30 fractions over 6 weeks
TemozolomideDrug
- 75 mg/m2/day for entire period of radiotherapy
- 150-200 mg/m2/day for 5 days every 28 days, 6 cycles total
Vitamin D3Drug
4000 IU started 1 week before commencing radiotherapy and discontinued immediately after completing last chemotherapy cycle
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: long term
Secondary outcomes (1)
Overall survival
Measured: long term
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study startMar 2011
- Primary completionMar 2013 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Konstantin Lavrenkov, MD, PhD, Principal investigator, Soroka University Miedical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181193
- Sponsor's protocol ID
- SOR504110CTIL
- Status last verified
- Aug 2010
- First submitted
- 18 Jul 2010
- Last updated
- 29 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Dose Vitamin D in Combination With Chemoradiotherapy in the Treatment of Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT01181193
- Acronym / sponsor ID
- SOR504110CTIL
- Conditions
- Glioblastoma Multiforme
- Keywords
- glioblastoma multiforme, chemoradiotherapy, vitamin D
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 13 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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)
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgeryCraniotomy with total or partial removal of the brain tumor | Other | – |
| Radiotherapy to tumour bed and/or residual tumour60 Gy in 30 fractions over 6 weeks | Radiation | – |
| Temozolomide1. 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 D34000 IU started 1 week before commencing radiotherapy and discontinued immediately after completing last chemotherapy cycle | Drug | – |
Primary outcome
Progression free survival
Time frame: long term
1 secondary outcome
Overall survival
Time frame: long term
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Konstantin Lavrenkov, MD, PhD principal investigator
Soroka University Miedical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Surgery, Radiotherapy to tumour bed and/or residual tumour and Temozolomide in people with Glioblastoma Multiforme, run by Soroka University Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Konstantin Lavrenkov, MD, PhD (+97286400537, constant@bgu.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: long term). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2011.