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A Phase II Trial of Concurrent Radiation Therapy and Temozolomide Followed by Temozolomide Plus Sorafenib in the First-Line Treatment of Patients With Glioblastoma Multiforme

Phase 2
18 Years
Not Enrolling
Glioblastoma Multiforme

Thank you

Trial Information

A Phase II Trial of Concurrent Radiation Therapy and Temozolomide Followed by Temozolomide Plus Sorafenib in the First-Line Treatment of Patients With Glioblastoma Multiforme

All patients entering this study will initially undergo combined modality treatment with
concurrent radiation therapy + temozolomide. Four weeks after completing radiation therapy,
patients will begin 6 months of follow-up treatment with oral temozolomide plus sorafenib.

Combined Modality Therapy - Radiation Therapy Radiotherapy must begin within ≤ 6 weeks of
surgery. One treatment of 2.0Gy will be given daily 5 days per week for a total of 60.0Gy
over 6 weeks. Temozolomide 75mg/m2 PO will be given daily, beginning on the first day of
radiation therapy and continuing through the last day of radiation therapy.

After completion of combined modality therapy, patients will have 4 weeks without any

Systemic Therapy Beginning 4 weeks after the completion of radiation therapy, patients will
receive 6 months of treatment with temozolomide and sorafenib. Temozolomide 150mg/m2 orally
will be administered days 1-5, and repeated every 28 days for 6 courses. Sorafenib 400mg PO
bid will be administered on days 1-28, repeated for 6 courses concurrently with temozolomide

Inclusion Criteria:

1. Histologically confirmed intracranial glioblastoma multiforme (WHO grade 4).

2. Patients who have had partial or complete surgical debulking are eligible, as are
those with inoperable glioblastoma.

3. No previous treatment for glioblastoma except for previous surgical debulking (i.e.
no previous radiotherapy, local chemotherapy, or systemic therapy).

4. ECOG performance status 0 or 1 (See Appendix C)

5. Age ≥ 18 years

6. Adequate bone marrow function: hemoglobin ≥ 9.0g/dL; ANC ≥ 1500/μL; platelet count ≥

7. Adequate liver function

- Total bilirubin ≤ 1.5 x ULN

- ALT and AST ≤ 2.5 x ULN

8. Serum creatinine < 1.5 x ULN

9. Women of child-bearing potential must have a negative serum pregnancy test performed
within 7 days prior to the start of treatment. Women must agree to not breast feed
while receiving study treatment.

10. Women of child-bearing potential and men must agree to use adequate contraception
(barrier method of birth control) while receiving study treatment. Women should use
adequate birth control for at least 3 months after the last administration of

11. INR < 1.5 or PT/PTT within normal limits in patients not receiving anticoagulation.
However, patients receiving anticoagulation treatment with an agent such as warfarin
or heparin are also eligible. For patients on warfarin, the INR should be measured
prior to initiation of sorafenib and monitored at least weekly, or as defined by the
local standard of care, until INR is stable.

12. Patients must have the ability to understand and the willingness to sign written
informed consent. A signed informed consent must be obtained prior to any
study-specific procedures.

Exclusion Criteria:

1. Patients must have the ability to swallow whole pills.

2. Active cardiac disease: congestive heart failure > class 2 NYHA (Appendix D);
unstable angina or new onset angina within the last 3 months; myocardial infarction
within the last 6 months.

3. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

4. Uncontrolled hypertension defined as systolic blood pressure > 150mm Hg or diastolic
pressure > 90mm Hg, despite optimal medical management

5. Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C

6. Active clinically serious infection > grade 2

7. Thrombotic or embolic events including cerebral vascular accident or TIAs within the
past 6 months

8. Pulmonary hemorrhage/bleeding event ≥ grade 2 within 4 weeks of the first dose of

9. Any other hemorrhage/bleeding event ≥ grade 3 within 4 weeks of the first dose of

10. Serious non-healing wound, ulcer, or bone fracture

11. Evidence or history of bleeding diathesis or coagulopathy

12. Major surgery, open biopsy, or significant traumatic injury within 4 weeks of
beginning treatment with sorafenib

13. Use of St. John's Wort or rifampicin

14. Known or suspected allergy to sorafenib or temozolomide

15. Any malabsorption problem

16. Other active malignancies, or treatment for invasive cancer within the last 2 years

Type of Study:


Study Design:

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

Outcome Measure:

Progression-free Survival.

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

John D. Hainsworth, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

April 2007

Completion Date:

August 2010

Related Keywords:

  • Glioblastoma Multiforme
  • Concurrent Radiation Therapy
  • Temozolomide
  • Sorafenib
  • First-line
  • Glioblastoma Multiforme
  • Phase II
  • Glioblastoma



South Texas Oncology and HematologySan Antonio, Texas  78229
Florida Cancer SpecialistsFort Myers, Florida  33901
Northeast Georgia Medical CenterGainesville, Georgia  30501
Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Virginia Cancer InstituteRichmond, Virginia  23230
Methodist Cancer CenterOmaha, Nebraska  68114
Center for Cancer and Blood DisordersBethesda, Maryland  20817
Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Tennessee OncologyNashville, Tennessee  37203
Oncology Hematology CareCincinnati, Ohio  45242