Status:
COMPLETED
Combination of Sorafenib and Radiation for Brain Metastases and Primary Brain Tumors
Lead Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborating Sponsors:
Bayer
Conditions:
Brain Metastases
Primary Brain Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 temo...
Detailed Description
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, ...
Eligibility Criteria
Inclusion
- Patients requiring a minimum 2-week course of radiation therapy
- Age \> or = 18
- All tumors of the central nervous system, or metastasis to the central nervous system.
- Measurable disease preferred but not required for eligibility
- Histologically or cytologically documented evidence of malignancy (for infratentorial and supratentorial glioma patients only).
- Radiographic evidence of brain metastasis
- ECOG performance status of 0 or 1
- Life expectancy of \> or = 3 months
Exclusion
- Patients receiving chemotherapy or other investigational drugs must be discontinued 14 days prior to enrollment.
- 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.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
- Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management.
- Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
- Active clinically serious infection \> CTCAE Grade 2
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00639262
Start Date
March 1 2008
End Date
September 1 2012
Last Update
May 2 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107