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

NCT ID: NCT00639262

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2012-09-30

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 temozolomide to determine tolerance of the combined treatments. Defining safe dosing of Sorafenib™ in this combination therapy will be achieved.

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, 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.

Conditions

Brain Metastases; Primary Brain Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1 - Brain Metastasis

Sorafenib and Radiotherapy

Group Type: EXPERIMENTAL

Sorafenib

Intervention Type: DRUG

Sorafenib 200mg twice daily during XRT and 30 days after. (Sorafenib will be escalated for both cohorts to determine maximum tolerated dose)

Radiotherapy

Intervention Type: RADIATION

Radiation Therapy (XRT)

Cohort 2 - Gliomas

Sorafenib and Radiotherapy, plus Temozolomide

Group Type: EXPERIMENTAL

Sorafenib

Intervention Type: DRUG

Sorafenib 200mg twice daily during XRT and 30 days after. (Sorafenib will be escalated for both cohorts to determine maximum tolerated dose)

Temozolomide

Intervention Type: DRUG

For Cohort 2 - Gliomas only.

Radiotherapy

Intervention Type: RADIATION

Radiation Therapy (XRT)

Interventions

Sorafenib

Sorafenib 200mg twice daily during XRT and 30 days after. (Sorafenib will be escalated for both cohorts to determine maximum tolerated dose)

Intervention Type: DRUG

Temozolomide

For Cohort 2 - Gliomas only.

Intervention Type: DRUG

Radiotherapy

Radiation Therapy (XRT)

Intervention Type: RADIATION

Other Intervention Names

Nexavar; Temodar; Temodal; XRT; Radiation therapy; radiation oncology

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

Sidney Kimmel Cancer Center at Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam Dicker, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

Related Links

http://www.KimmelCancerCenter.org

Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center

http://www.JeffersonHospital.org

Thomas Jefferson University Hospitals

Other Identifiers

2006-58

Identifier Type: OTHER

Identifier Source: secondary_id

JT 1208

Identifier Type: OTHER

Identifier Source: secondary_id

07P.381

Identifier Type: -

Identifier Source: org_study_id