NCT00639262

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2008

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 20, 2008

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

May 2, 2025

Status Verified

May 1, 2025

Enrollment Period

4.5 years

First QC Date

March 13, 2008

Last Update Submit

May 1, 2025

Conditions

Brain MetastasesPrimary Brain Tumors

Keywords

SorafenibRadiation TherapyRadiotherapyTemozolomideBrain MetastasesBrain Tumors

Outcome Measures

Primary Outcomes (1)

  • 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.

    30 days post-treatment

Secondary Outcomes (3)

  • Response Rate

    30 days post-treatment

  • Prediction of 1-year Recurrence

    1 year post-treatment

  • Safety and Toxicity of Sorafenib

    30 days post-treatment

Study Arms (2)

Cohort 1 - Brain Metastasis

EXPERIMENTAL

Sorafenib and Radiotherapy

Drug: SorafenibRadiation: Radiotherapy

Cohort 2 - Gliomas

EXPERIMENTAL

Sorafenib and Radiotherapy, plus Temozolomide

Drug: SorafenibDrug: TemozolomideRadiation: Radiotherapy

Interventions

SorafenibDRUG

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

Also known as: Nexavar
Cohort 1 - Brain MetastasisCohort 2 - Gliomas
TemozolomideDRUG

For Cohort 2 - Gliomas only.

Also known as: Temodar, Temodal
Cohort 2 - Gliomas
RadiotherapyRADIATION

Radiation Therapy (XRT)

Also known as: XRT, Radiation therapy, radiation oncology
Cohort 1 - Brain MetastasisCohort 2 - Gliomas

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

MeSH Terms

Conditions

Brain Neoplasms

Interventions

SorafenibTemozolomideRadiotherapyRadiation

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingDacarbazineTriazenesImidazolesAzolesTherapeuticsPhysical Phenomena

Study Officials

  • Adam Dicker, MD, PhD

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2008

First Posted

March 20, 2008

Study Start

March 1, 2008

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

May 2, 2025

Record last verified: 2025-05

Locations

US(1)