- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01276210
Sorafenib Tosylate and Stereotactic Radiosurgery in Treating Patients With Brain Metastases
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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
PRIMARY OBJECTIVES:
I. 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:
I. 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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 1
Kontakte und Standorte
Studienorte
-
-
Tennessee
-
Nashville, Tennessee, Vereinigte Staaten, 37232-6838
- Vanderbilt-Ingram Cancer Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Behandlung
Siehe Detaillierte Beschreibung
|
Korrelative Studien
PO gegeben
Andere Namen:
Unterziehen Sie sich einer stereotaktischen Radiochirurgie
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
The maximum tolerated dose (MTD) of combining sorafenib with SRS
Zeitfenster: At 1 month
|
At 1 month
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Intra-cranial progression-free survival (PFS)
Zeitfenster: At 6 months
|
At 6 months
|
Overall survival(OS) in study patient population
Zeitfenster: at 6 months
|
at 6 months
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Anuradha Chakravarthy, Vanderbilt-Ingram Cancer Center
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Gehirns
- Erkrankungen des zentralen Nervensystems
- Erkrankungen des Nervensystems
- Neubildungen
- Neubildungen nach Standort
- Neubildungen des zentralen Nervensystems
- Neubildungen des Nervensystems
- Neubildungen des Gehirns
- Molekulare Mechanismen der pharmakologischen Wirkung
- Enzym-Inhibitoren
- Antineoplastische Mittel
- Proteinkinase-Inhibitoren
- Sorafenib
Andere Studien-ID-Nummern
- VICC RAD1060
- NCI-2010-02407 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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