Status:
UNKNOWN
Vitamin D for Treatment of Glioblastoma Multiforme
Lead Sponsor:
Soroka University Medical Center
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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 ch...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01181193
Start Date
March 1 2011
End Date
March 1 2014
Last Update
March 29 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Soroka University Medical Center
Beersheba, Israel, 84101