Know Cancer

forgot password

Phase I Study of the Combination of Sorafenib and Radiation Therapy -/+ Temozolomide for the Treatment of Patients With Brain Metastases and Primary Brain Tumors

Phase 1
18 Years
Open (Enrolling)
Brain Metastases, Primary Brain Tumors

Thank you

Trial Information

Phase I Study of the Combination of Sorafenib and Radiation Therapy -/+ Temozolomide for the Treatment of Patients With Brain Metastases and Primary Brain Tumors

The current standard of care for patients with brain metastatic malignancies is to receive
radiation therapy alone, while the standard of care for patients with high grade primary
brain malignancies, astrocytomas, is to receive to receive concurrent temozolomide with
radiation therapy. In this phase I study, based on the range of efficacy of kinase
inhibitors and its ability to cross the blood-brain barrier we will conduct two parallel
studies. The first is to combine sorafenib and radiation therapy for the treatment of
patients with brain metastases and the second is to combine sorafenib with temozolomide for
primary brain tumors.

Inclusion Criteria:

1. Patients requiring a minimum 2-week course of radiation therapy

2. Age > or = 18

3. All tumors of the central nervous system, or metastasis to the central nervous

4. Measurable disease preferred but not required for eligibility

5. Histologically or cytologically documented evidence of malignancy (for infratentorial
and supratentorial glioma patients only).

6. Radiographic evidence of brain metastasis

7. ECOG performance status of 0 or 1

8. Life expectancy of > or = 3 months

Exclusion Criteria:

1. Patients receiving chemotherapy or other investigational drugs must be discontinued
14 days prior to enrollment.

2. Cardiac disease: Congestive heart failure > class II NYHA. Patients must not have
unstable angina (anginal symptoms at rest) or new onset angina (began within the last
3 months) or myocardial infarction within the past 6 months.

3. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.

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

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

6. Active clinically serious infection > CTCAE Grade 2

Type of Study:


Study Design:

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

Outcome Measure:

Maximum Tolerated Dose of Sorafenib

Outcome Description:

To determine the maximum tolerated dose (MTD) and a recommended phase II dose (RP2D) of Sorafenib and radiotherapy -/+ temozolomide patients with malignancies of the brain.

Outcome Time Frame:

30 days post-treatment

Safety Issue:


Principal Investigator

Adam Dicker, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Thomas Jefferson University


United States: Institutional Review Board

Study ID:




Start Date:

March 2008

Completion Date:

March 2013

Related Keywords:

  • Brain Metastases
  • Primary Brain Tumors
  • Sorafenib
  • Radiation Therapy
  • Radiotherapy
  • Temozolomide
  • Brain Metastases
  • Brain Tumors
  • Brain Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary



Thomas Jefferson University Philadelphia, Pennsylvania  19107-6541