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High-Dose Vitamin D in Combination With Chemoradiotherapy in the Treatment of Glioblastoma Multiforme


Phase 1/Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Glioblastoma Multiforme

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Trial Information

High-Dose Vitamin D in Combination With Chemoradiotherapy in the Treatment of Glioblastoma Multiforme


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Time Frame:

long term

Safety Issue:

Yes

Principal Investigator

Konstantin Lavrenkov, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Soroka University Miedical Center

Authority:

Israel: Ministry of Health

Study ID:

SOR504110CTIL

NCT ID:

NCT01181193

Start Date:

March 2011

Completion Date:

March 2014

Related Keywords:

  • Glioblastoma Multiforme
  • glioblastoma multiforme
  • chemoradiotherapy
  • vitamin D
  • Glioblastoma

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