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Tumors Metastatic to BrainPhase 1NCT01276210

Sorafenib Tosylate and Stereotactic Radiosurgery in Treating Patients With Brain Metastases

A Phase 1 study testing sorafenib tosylate, stereotactic radiosurgery and laboratory biomarker analysis in people with Tumors Metastatic to Brain, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Stereotactic radiosurgery (SRS) may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tumors Metastatic to Brain
What is being tested?
sorafenib tosylate, stereotactic radiosurgery and laboratory biomarker analysis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteUnited States
Study dates
Feb 2011to Jun 2017
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

  • Histologically confirmed cancer with 1-4 brain metastases (except lymphoma or small cell histologies)
  • ECOG PS 0 or 1
  • Patients are candidates for stereotactic radiosurgery as determined by the treating radiation oncologist. Intra-cranial tumors must measure 4cm or less in greatest dimension. Patients may have received prior neurosurgical resection(s) of intra-cranial metastases if their operation(s) was (were) completed at least 6 months prior to study enrollment. Patients may have had prior whole brain radiation therapy (WBRT) if it was completed at least 6 months prior to study enrollment.
  • Age ≥ 18 years and willing and able to sign a written informed consent; a signed informed consent must be obtained prior to any study specific procedures
  • INR < 1.5 or a PT/PTT within normal limits; patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate; for patients on warfarin, the INR should be measured prior to initiation of sorafenib and monitored at least weekly (INR must be therapeutic in the range of 2-3)
  • Subjects must receive 1st dose of sorafenib 5-7 days prior to administration of Stereotactic Radiosurgery.

Who cannot join

  • 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
  • Unable to undergo brain MRI
  • CNS metastases from lymphoma or small cell lung cancer
  • Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
  • Uncontrolled hypertension defined as systolic blood pressure > 140mm Hg or diastolic pressure > 90 mm Hg, despite optimal medical management
  • Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C
Show all 31Show fewer
  • Active clinically serious infection > CTCAE v 4.0 Grade 2
  • Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months
  • Pulmonary hemorrhage/bleeding event >= CTCAE v 3.0 Grade 2 within 4 weeks of first dose of study drug
  • Any other hemorrhage/bleeding event >= CTCAE v 3.0 Grade 3 within 4 weeks of first dose of study drug
  • Serious non-healing wound, ulcer, or bone fracture
  • Any drug that results in hepatic enzyme induction such as anti-convulsants (dilantin, depakote, tegretol, phenobarbital); keppra is allowed
  • Evidence or history of bleeding diathesis or coagulopathy
  • Any pulmonary hemorrhage CTCAE v 4.0 Grade 2 or higher within 4 weeks of first study drug
  • Any other bleeding or hemorrhage CTCAE v 4.0 Grade 3 or higher within 4 weeks of first drug
  • Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug
  • Use of St. John's Wort or rifampin (rifampicin) within the last 8 weeks
  • Known or suspected allergy to sorafenib
  • Any condition that impairs patient's ability to swallow whole pills
  • Concurrent investigational drugs
  • Concurrent steroids are allowed if Dexamethasone dose is =< 16mg daily; if feasible, steroids should be weaned off once sorafenib has been initiated
  • Prior therapy with sorafenib or other tyrosine kinase inhibitors within the last 12 months; patients are allowed to have been on prior bevacizumab therapy as long as it was stopped at least 6-8 weeks prior to enrolling on this trial
  • Any malabsorption problem
  • Hemoglobin =< 9.0 g/dl
  • Absolute neutrophil count (ANC) =< 1,500/mm^3
  • Platelet count =< 100,000/mm^3
  • Total bilirubin >= 1.5 times upper limit of normal (ULN)
  • ALT and AST >= 2.5 times the ULN ( =< 5 x ULN for patients with liver involvement)
  • Creatinine >= 1.5 times ULN
  • Women of childbearing potential with a positive serum pregnancy test performed within 7 days prior to the start of treatment; women and men of childbearing potential that do not agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation; men who do not agree to use adequate birth control for at least three months after the last administration of sorafenib
  • All toxicities from prior therapies must have resolved to CTCAE v3.0 Grade I or better by the time of study enrollment

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6838

Other trials in United States

About this study

Official title: A Phase I Trial of Sorafenib and Stereotactic Radiosurgery for Patients With 1-4 Brain Metastases

RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Stereotactic radiosurgery (SRS) may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving sorafenib tosylate together with SRS may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and the best dose of sorafenib tosylate when given together with SRS in treating patients with brain metastases

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the safety, tolerability and maximum tolerated dose (MTD) of sorafenib, when administered in combination with SRS to patients with 1-4 metastatic brain tumors.

SECONDARY OBJECTIVES:

  1. To assess the six-month intra-cranial progression-free survival (PFS) of sorafenib when administered in combination with SRS to patients with 1-4 metastatic brain tumors. PFS is defined as the time to intra-cranial tumor progression or death.

II. To assess the six-month overall survival (OS) of sorafenib when administered in combination with SRS to patients with 1-4 metastatic brain tumors.

III. To compare results to patients who are treated with SRS alone (concurrent controls).

OUTLINE: This is a dose-escalation study of sorafenib tosylate.

Patients receive oral (PO) sorafenib tosylate once daily and undergo SRS 5-7 days later. Treatment with sorafenib continues for 2 weeks after SRS in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 8, 26, and 52 weeks.

Being tested
sorafenib tosylate, stereotactic radiosurgery, laboratory biomarker analysis
Medical subject headings
Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sorafenib tosylateDrug

    Also called BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar

    Given PO

  • stereotactic radiosurgeryRadiation

    Undergo stereotactic radiosurgery

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT01276210
Study groupRoleWhat they receive
TreatmentExperimentalSee Detailed Description
Receives: Drug: sorafenib tosylate; Radiation: stereotactic radiosurgery; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The maximum tolerated dose (MTD) of combining sorafenib with SRS

    Measured: At 1 month

Secondary outcomes (2)

  1. Intra-cranial progression-free survival (PFS)

    Measured: At 6 months

  2. Overall survival(OS) in study patient population

    Measured: at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionJul 2015
  4. Study completionJun 2017

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01276210
Sponsor's protocol ID
VICC RAD1060
Other IDs
NCI-2010-02407
Status last verified
Jul 2017
First submitted
11 Jan 2011
Last updated
17 Jul 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing sorafenib tosylate, stereotactic radiosurgery and laboratory biomarker analysis in people with Tumors Metastatic to Brain, run by Vanderbilt-Ingram Cancer Center 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 6 inclusion and 31 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 17 Jul 2017. 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?

The maximum tolerated dose (MTD) of combining sorafenib with SRS (time frame: At 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01276210.

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 17 Jul 2017.

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