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

Primary Purpose

Brain Metastases, Primary Brain Tumors

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Sorafenib

Temozolomide

Radiotherapy

About this trial

This is an interventional treatment trial for Brain Metastases focused on measuring Sorafenib, Radiation Therapy, Radiotherapy, Temozolomide, Brain Metastases, Brain Tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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

Sites / Locations

Thomas Jefferson University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cohort 1 - Brain Metastasis

Cohort 2 - Gliomas

Arm Description

Sorafenib and Radiotherapy

Sorafenib and Radiotherapy, plus Temozolomide

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose of Sorafenib

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.

Secondary Outcome Measures

Response Rate

Response rate (in those patients with measurable disease)

Prediction of 1-year Recurrence

Determine if an increase in urinary VEGF and MMP levels, from the end of treatment to a patient's 1-month follow-up examination, is predictive of 1-year recurrence

Safety and Toxicity of Sorafenib

To evaluate the safety and toxicity profile of Sorafenib in combination with radiation therapy -/+ temozolomide

Full Information

NCT ID

NCT00639262

First Posted

March 13, 2008

Last Updated

October 19, 2016

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Collaborators

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00639262

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Collaborators

Bayer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Metastases, Primary Brain Tumors

Keywords

Sorafenib, Radiation Therapy, Radiotherapy, Temozolomide, Brain Metastases, Brain Tumors

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1 - Brain Metastasis

Arm Type

Experimental

Arm Description

Sorafenib and Radiotherapy

Arm Title

Cohort 2 - Gliomas

Arm Type

Experimental

Arm Description

Sorafenib and Radiotherapy, plus Temozolomide

Intervention Type

Drug

Intervention Name(s)

Sorafenib

Other Intervention Name(s)

Nexavar

Intervention Description

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

Intervention Name(s)

Temozolomide

Other Intervention Name(s)

Temodar, Temodal

Intervention Description

For Cohort 2 - Gliomas only.

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy

Other Intervention Name(s)

XRT, Radiation therapy, radiation oncology

Intervention Description

Radiation Therapy (XRT)

Primary Outcome Measure Information:

Title

Maximum Tolerated Dose of Sorafenib

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.

Time Frame

30 days post-treatment

Secondary Outcome Measure Information:

Title

Response Rate

Description

Response rate (in those patients with measurable disease)

Time Frame

30 days post-treatment

Title

Prediction of 1-year Recurrence

Description

Determine if an increase in urinary VEGF and MMP levels, from the end of treatment to a patient's 1-month follow-up examination, is predictive of 1-year recurrence

Time Frame

1 year post-treatment

Title

Safety and Toxicity of Sorafenib

Description

To evaluate the safety and toxicity profile of Sorafenib in combination with radiation therapy -/+ temozolomide

Time Frame

30 days post-treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adam Dicker, MD, PhD

Organizational Affiliation

Thomas Jefferson University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Thomas Jefferson University

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.JeffersonHospital.org

Description

Thomas Jefferson University Hospitals

Learn more about this trial

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

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