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- Klinische Studie NCT00352521
Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) With Bevacizumab and Irinotecan for Malignant Glioma
Dynamic Contrast-Enhanced Magnetic Resonance Imaging With Bevacizumab in Combination With Irinotecan for Malignant Gliomas
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also block blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with irinotecan may kill more tumor cells. Diagnostic procedures, such as MRI, may help doctors predict a patient's response to treatment and help plan the best treatment.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with irinotecan works in treating patients with recurrent malignant glioma and how well MRI predicts response to treatment.
Studienübersicht
Status
Detaillierte Beschreibung
OBJECTIVES:
Primary
- Examine the effect of bevacizumab and irinotecan on vascular permeability and blood flow in patients with recurrent malignant gliomas.
Secondary
- Determine the reproducibility of dynamic contrast-enhanced (DCE-MRI) in malignant gliomas.
- Determine the predictive value of DCE-MRI in patients with recurrent malignant gliomas treated with bevacizumab and irinotecan.
- Describe the activity of the combination of bevacizumab with irinotecan as measured by response rate and progression-free survival.
- Describe the toxicity associated with the administration of bevacizumab with irinotecan.
OUTLINE: Patients receive bevacizumab IV on days 1, 15, and 29 and irinotecan IV on days 2, 15, and 29 during the first 6-week cycle. After the first cycle, the irinotecan and bevacizumab will be given on days 1, 15 and 29. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients also undergo dynamic contrast-enhanced MRI 4 times.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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North Carolina
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Durham, North Carolina, Vereinigte Staaten, 27710
- Duke Comprehensive Cancer Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
DISEASE CHARACTERISTICS:
Diagnosis of any of the following malignant gliomas:
- Glioblastoma multiforme
- Anaplastic astrocytoma
- Grade 3 or greater WHO astrocytic, oligodendroglial, or mixed glial tumors that were initially diagnosed by histologic examination of a tumor specimen obtained from biopsy or resection
Recurrent disease
- No more than 3 prior recurrences
- Measurable recurrent or residual primary CNS neoplasm on contrast-enhanced MRI or CT scan
- No evidence of CNS hemorrhage on baseline MRI or CT scan
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Hematocrit > 29%
- Absolute neutrophil count > 1,500/mm³
- Platelet count > 125,000/mm³
- Creatinine < 1.5 mg/dL
- SGOT < 1.5 times upper limit of normal (ULN)
- Bilirubin < 1.5 times ULN
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No active infection
- No significant traumatic injury within the past 28 days
PRIOR CONCURRENT THERAPY:
- At least 6 weeks since prior surgical resection
- More than 28 days since prior major surgical procedure or open biopsy
- More than 7 days since prior minor surgical procedure, fine-needle aspirations, or core biopsies
- At least 6 weeks since prior chemotherapy*
- At least 4 weeks since prior radiotherapy*
- No concurrent immunosuppressive agents
- No concurrent therapeutic anticoagulation
- Concurrent corticosteroids allowed if dose has been stable for 1 week prior to study entry NOTE: * Unless there is unequivocal evidence of progressive disease
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 |
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Experimental: Bevacizumab and irinotecan
The bevacizumab will be dosed at 10 mg/kg every 14 days (days 1, 15 and 29) and the irinotecan on days 2, 15, and 29 of the first six week schedule.
The irinotecan dose will depend on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED).
If the patient is on an EIAED, the patient will receive 340 mg/m2 on days 2, 15, and 29 of the first six week schedule.
If the patient is not on an EIAED, the dose of irinotecan will be 125 mg/m2 on days 2, 15, and 29 of the first six week schedule.
After the first cycle, the irinotecan and bevacizumab will be given on days 1, 15 and 29.
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Andere Namen:
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Correlation of the acute permeability and blood flow response (24-48 hours) with progression-free survival (PFS)
Zeitfenster: 1 year
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Assessed by DCE-MRI
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1 year
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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Overall Survival and Tumor Response
Zeitfenster: 2 years
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2 years
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Incidence and severity of central nervous system (CNS) hemorrhage and systemic hemorrhage
Zeitfenster: 2 years
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2 years
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Studienstuhl: James J. Vredenburgh, MD, Duke Cancer Institute
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
- erwachsenes Glioblastom
- adultes Riesenzell-Glioblastom
- erwachsenes Gliosarkom
- rezidivierender Hirntumor bei Erwachsenen
- anaplastisches Astrozytom des Erwachsenen
- anaplastisches Ependymom des Erwachsenen
- anaplastisches Oligodendrogliom des Erwachsenen
- erwachsenes gemischtes Gliom
- erwachsenes Astrozytom der Zirbeldrüse
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Nervensystems
- Neubildungen nach histologischem Typ
- Neubildungen
- Neubildungen nach Standort
- Neubildungen, Drüsen und Epithelien
- Neubildungen, Neuroepithel
- Neuroektodermale Tumoren
- Neoplasmen, Keimzelle und Embryonal
- Neubildungen, Nervengewebe
- Gliom
- Neubildungen des Nervensystems
- Neubildungen des zentralen Nervensystems
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Enzym-Inhibitoren
- Antineoplastische Mittel
- Topoisomerase-Inhibitoren
- Antineoplastische Mittel, immunologische
- Angiogenese-Inhibitoren
- Angiogenese-modulierende Mittel
- Wuchsstoffe
- Wachstumshemmer
- Topoisomerase I-Inhibitoren
- Bevacizumab
- Irinotecan
Andere Studien-ID-Nummern
- Pro00012387
- DUMC-8053-05-12R0
- CDR0000481476 (Andere Kennung: NCI)
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