- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00544817
Radiation Therapy and Temozolomide Followed by Temozolomide Plus Sorafenib for Glioblastoma Multiforme
A Phase II Trial of Concurrent Radiation Therapy and Temozolomide Followed by Temozolomide Plus Sorafenib in the First-Line Treatment of Patients With Glioblastoma Multiforme
The mechanism of action of sorafenib makes it an interesting drug to investigate in the treatment of patients with glioblastoma multiforme. Efficacy of agents with anti-angiogenic activity has already been demonstrated and the PDGF receptor target may also be pertinent in glioblastoma. The combination of temozolomide plus sorafenib has been investigated previously in the treatment of patients with advanced melanoma. The combination was generally well tolerated; in previously untreated patients, a standard dose of sorafenib (400mg PO bid) was administered with temozolomide 150mg/m2 PO daily for 5 days, repeated every 28 days (23).
In this multicenter phase II study, patients with newly diagnosed glioblastoma will receive standard treatment, including initial debulking surgical resection (if feasible) followed by high-dose radiation therapy with concurrent temozolomide. After completion of radiation therapy, patients will continue treatment with temozolomide (150mg/m2 days 1-5) and sorafenib (400mg PO bid daily), repeated at 28-day intervals for 6 cycles.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
All patients entering this study will initially undergo combined modality treatment with concurrent radiation therapy + temozolomide. Four weeks after completing radiation therapy, patients will begin 6 months of follow-up treatment with oral temozolomide plus sorafenib.
Combined Modality Therapy - Radiation Therapy Radiotherapy must begin within ≤ 6 weeks of surgery. One treatment of 2.0Gy will be given daily 5 days per week for a total of 60.0Gy over 6 weeks. Temozolomide 75mg/m2 PO will be given daily, beginning on the first day of radiation therapy and continuing through the last day of radiation therapy.
After completion of combined modality therapy, patients will have 4 weeks without any therapy.
Systemic Therapy Beginning 4 weeks after the completion of radiation therapy, patients will receive 6 months of treatment with temozolomide and sorafenib. Temozolomide 150mg/m2 orally will be administered days 1-5, and repeated every 28 days for 6 courses. Sorafenib 400mg PO bid will be administered on days 1-28, repeated for 6 courses concurrently with temozolomide
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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Florida
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Fort Myers, Florida, Vereinigte Staaten, 33901
- Florida Cancer Specialists
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Georgia
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Gainesville, Georgia, Vereinigte Staaten, 30501
- Northeast Georgia Medical Center
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Maryland
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Bethesda, Maryland, Vereinigte Staaten, 20817
- Center for Cancer and Blood Disorders
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-
Michigan
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Grand Rapids, Michigan, Vereinigte Staaten, 49503
- Grand Rapids Clinical Oncology Program
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Nebraska
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Omaha, Nebraska, Vereinigte Staaten, 68114
- Methodist Cancer Center
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Ohio
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Cincinnati, Ohio, Vereinigte Staaten, 45242
- Oncology Hematology Care
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South Carolina
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Spartanburg, South Carolina, Vereinigte Staaten, 29303
- Spartanburg Regional Medical Center
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Tennessee
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Nashville, Tennessee, Vereinigte Staaten, 37203
- Tennessee Oncology
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Texas
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San Antonio, Texas, Vereinigte Staaten, 78258
- South Texas Oncology and Hematology
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Virginia
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Richmond, Virginia, Vereinigte Staaten, 23235
- Virginia Cancer Institute
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Histologically confirmed intracranial glioblastoma multiforme (WHO grade 4).
- Patients who have had partial or complete surgical debulking are eligible, as are those with inoperable glioblastoma.
- No previous treatment for glioblastoma except for previous surgical debulking (i.e. no previous radiotherapy, local chemotherapy, or systemic therapy).
- ECOG performance status 0 or 1 (See Appendix C)
- Age ≥ 18 years
- Adequate bone marrow function: hemoglobin ≥ 9.0g/dL; ANC ≥ 1500/μL; platelet count ≥ 100,000/μL.
Adequate liver function
- Total bilirubin ≤ 1.5 x ULN
- ALT and AST ≤ 2.5 x ULN
- Serum creatinine < 1.5 x ULN
- Women of child-bearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment. Women must agree to not breast feed while receiving study treatment.
- Women of child-bearing potential and men must agree to use adequate contraception (barrier method of birth control) while receiving study treatment. Women should use adequate birth control for at least 3 months after the last administration of sorafenib.
- INR < 1.5 or PT/PTT within normal limits in patients not receiving anticoagulation. However, patients receiving anticoagulation treatment with an agent such as warfarin or heparin are also eligible. For patients on warfarin, the INR should be measured prior to initiation of sorafenib and monitored at least weekly, or as defined by the local standard of care, until INR is stable.
- Patients must have the ability to understand and the willingness to sign written informed consent. A signed informed consent must be obtained prior to any study-specific procedures.
Exclusion Criteria:
- Patients must have the ability to swallow whole pills.
- Active cardiac disease: congestive heart failure > class 2 NYHA (Appendix D); unstable angina or new onset angina within the last 3 months; myocardial infarction within the last 6 months.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- Uncontrolled hypertension defined as systolic blood pressure > 150mm Hg or diastolic pressure > 90mm Hg, despite optimal medical management
- Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C infection
- Active clinically serious infection > grade 2
- Thrombotic or embolic events including cerebral vascular accident or TIAs within the past 6 months
- Pulmonary hemorrhage/bleeding event ≥ grade 2 within 4 weeks of the first dose of sorafenib
- Any other hemorrhage/bleeding event ≥ grade 3 within 4 weeks of the first dose of sorafenib
- Serious non-healing wound, ulcer, or bone fracture
- Evidence or history of bleeding diathesis or coagulopathy
- Major surgery, open biopsy, or significant traumatic injury within 4 weeks of beginning treatment with sorafenib
- Use of St. John's Wort or rifampicin
- Known or suspected allergy to sorafenib or temozolomide
- Any malabsorption problem
- Other active malignancies, or treatment for invasive cancer within the last 2 years
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: Combination Therapy
In the combined modality portion of the study, patients were administered: Radiation Therapy - 2 Gy/fraction, Single daily fractions M-F, to 60 Gy total Temozolomide - 75 mg/m2 by mouth once daily Patients took a four week break before beginning follow-up systemic therapy: Temozolomide - 150 mg /m2 by mouth on days 1-5 every 28 days for 6 cycles Sorafenib - 400 mg by mouth twice a day for 6 months |
2 Gy/fraction, single daily fractions M-F, to 60 Gy total
In Combined Modality Therapy, administered as 75 mg/m2 by mouth once daily In follow-up systemic therapy, administered as 150 mg/m2 by mouth on days 1-5 every 28 days for 6 cycles
Andere Namen:
In follow-up systemic therapy, administered as 400 mg by mouth twice daily for 6 months
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Progression-free Survival
Zeitfenster: 18 months
|
Defined as the duration of time from start of treatment to time of progression or death, whichever comes first.
|
18 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Overall Survival
Zeitfenster: 18 months
|
Defined as Day 1 of protocol treatment to date of death from any cause.
|
18 months
|
Objective Response
Zeitfenster: every 8 weeks until disease progression, estimated 18 months
|
The number of patients with complete or partial responses measured from the time of initial response to documented tumor progression. Radiologic response was defined using the Macdonald criteria. The Macdonald criteria divides response into 4 types of response based on imaging (MRI) and clinical features, as follows: 1) complete response (CR); 2) partial response (PR); 3) stable disease (SD); and 4) progression (PD). Criteria: CR: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks, no new lesions. No corticosteroids, clinically stable or improved. PR: >=50% decrease of all measurable enhancing lesions, sustained for at least 4 weeks, no new lesions. Stable or reduced corticosteroids, clinically stable or improved. SD: does not qualify for complete response, partial response or progression. Clinically stable. PD: >= 25% increase in enhancing lesions, any new lesions. Clinical deterioration. |
every 8 weeks until disease progression, estimated 18 months
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Studienstuhl: John D. Hainsworth, M.D., SCRI Development Innovations, LLC
Publikationen und hilfreiche 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 (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Neubildungen nach histologischem Typ
- Neubildungen
- Neubildungen, Drüsen und Epithelien
- Astrozytom
- Gliom
- Neubildungen, Neuroepithel
- Neuroektodermale Tumoren
- Neoplasmen, Keimzelle und Embryonal
- Neubildungen, Nervengewebe
- Glioblastom
- Molekulare Mechanismen der pharmakologischen Wirkung
- Enzym-Inhibitoren
- Antineoplastische Mittel
- Antineoplastische Mittel, alkylierend
- Alkylierungsmittel
- Proteinkinase-Inhibitoren
- Temozolomid
- Sorafenib
Andere Studien-ID-Nummern
- SCRI CNS 09
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 .
Klinische Studien zur Glioblastoma multiforme
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Stony Brook UniversityGarnett McKeen Laboratory Inc.AbgeschlossenSicherheitsstudie zur Dosisbewertung bei Personen mit Astrozytom, die PolyMVA einnehmen (DESSTINI_A)Glioblastoma Multiform (Grad IV Astrozytom)Vereinigte Staaten
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Milton S. Hershey Medical CenterRekrutierungGlioblastom | Glioblastoma multiforme | Glioblastoma multiforme, Erwachsener | Glioblastoma Multiforme des GehirnsVereinigte Staaten
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Royan InstituteTehran University of Medical SciencesRekrutierungRezidivierendes Glioblastom | Glioblastom MultiformIran, Islamische Republik
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Milton S. Hershey Medical CenterNational Cancer Institute (NCI)RekrutierungGlioblastom | Glioblastoma multiforme | Glioblastoma multiforme, Erwachsener | Glioblastoma Multiforme des GehirnsVereinigte Staaten
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Jasper GerritsenMassachusetts General Hospital; Universitaire Ziekenhuizen KU Leuven; University... und andere MitarbeiterRekrutierungGlioblastom | Glioblastoma multiforme | Glioblastom, IDH-Wildtyp | Glioblastoma multiforme, Erwachsener | Glioblastoma Multiforme des GehirnsVereinigte Staaten, Belgien, Schweiz, Deutschland, Niederlande
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University of UtahZurückgezogenGlioblastoma multiforme (GBM)Vereinigte Staaten
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TVAX BiomedicalFDA Office of Orphan Products DevelopmentRekrutierungGlioblastoma Multiforme des GehirnsVereinigte Staaten
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Shenzhen Geno-Immune Medical InstituteAnmeldung auf EinladungGlioblastoma multiforme | Glioblastoma Multiforme des GehirnsChina
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University of Roma La SapienzaAbgeschlossenGlioblastoma Multiforme des Gehirns
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Imperial College LondonRekrutierungGlioblastoma Multiforme des GehirnsVereinigtes Königreich
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