Combination of Sorafenib and Radiation for Brain Metastases and Primary Brain Tumors

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Sorafenib™ has the potential to inhibit tumor growth, tumor angiogenesis , and enhance radiation response. This study will test the combination of Sorafenib™ and radiation therapy with or without temozolomide to determine tolerance of the combined treatments. Defining safe dosing of Sorafenib™ in this combination therapy will be achieved.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Collaborator: Bayer
• Treatments: Dacarbazine; Niacinamide; Sorafenib; Temozolomide

Criteria

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 system.

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