Brain MetastasesPhase 1NCT00639262
Combination of Sorafenib and Radiation for Brain Metastases and Primary Brain Tumors
A Phase 1 study testing Sorafenib, Temozolomide and Radiotherapy in people with Brain Metastases and Primary Brain Tumors, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases, Primary Brain Tumors
- What is being tested?
- Sorafenib, Temozolomide and Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Sep 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
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
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.
Read the 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
- Being tested
- Sorafenib, Temozolomide, Radiotherapy
- Keywords
- Sorafenib, Radiation Therapy, Radiotherapy, Temozolomide, Brain Metastases, Brain Tumors
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SorafenibDrug
Also called Nexavar
Sorafenib 200mg twice daily during XRT and 30 days after. (Sorafenib will be escalated for both cohorts to determine maximum tolerated dose)
TemozolomideDrug
Also called Temodar, Temodal
For Cohort 2 - Gliomas only.
RadiotherapyRadiation
Also called XRT, Radiation therapy, radiation oncology
Radiation Therapy (XRT)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - Brain Metastasis | Experimental | Sorafenib and Radiotherapy Receives: Drug: Sorafenib; Radiation: Radiotherapy |
| Cohort 2 - Gliomas | Experimental | Sorafenib and Radiotherapy, plus Temozolomide Receives: Drug: Sorafenib; Drug: Temozolomide; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days post-treatment
Secondary outcomes (3)
Response Rate
Response rate (in those patients with measurable disease)
Measured: 30 days post-treatment
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
Measured: 1 year post-treatment
Safety and Toxicity of Sorafenib
To evaluate the safety and toxicity profile of Sorafenib in combination with radiation therapy -/+ temozolomide
Measured: 30 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Adam Dicker, MD, PhD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639262
- Sponsor's protocol ID
- 07P.381
- Other IDs
- 2006-58, JT 1208
- Status last verified
- May 2025
- First submitted
- 13 Mar 2008
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00639262
- Acronym / sponsor ID
- 07P.381
- Conditions
- Brain Metastases, Primary Brain Tumors
- Keywords
- Sorafenib, Radiation Therapy, Radiotherapy, Temozolomide, Brain Metastases, Brain Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Mar 2008
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 20 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - Brain Metastasis | Experimental | Drug: Sorafenib, Radiation: RadiotherapySorafenib and Radiotherapy |
| Cohort 2 - Gliomas | Experimental | Drug: Sorafenib, Drug: Temozolomide, Radiation: RadiotherapySorafenib and Radiotherapy, plus Temozolomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SorafenibAlso: NexavarSorafenib 200mg twice daily during XRT and 30 days after. (Sorafenib will be escalated for both cohorts to determine maximum tolerated dose) | Drug | Cohort 1 - Brain Metastasis, Cohort 2 - Gliomas |
| TemozolomideAlso: Temodar, TemodalFor Cohort 2 - Gliomas only. | Drug | Cohort 2 - Gliomas |
| RadiotherapyAlso: XRT, Radiation therapy, radiation oncologyRadiation Therapy (XRT) | Radiation | Cohort 1 - Brain Metastasis, Cohort 2 - Gliomas |
Primary outcome
Maximum Tolerated Dose of Sorafenib
Time frame: 30 days post-treatment
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.
3 secondary outcomes
Response Rate
Time frame: 30 days post-treatment
Prediction of 1-year Recurrence
Time frame: 1 year post-treatment
Safety and Toxicity of Sorafenib
Time frame: 30 days post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer CenterLink provided by the sponsor.
- Thomas Jefferson University HospitalsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Dicker, MD, PhD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sorafenib, Temozolomide and Radiotherapy in people with Brain Metastases and Primary Brain Tumors, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose of Sorafenib (time frame: 30 days post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.