- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
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North Carolina
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Durham, North Carolina, Förenta staterna, 27710
- Duke Comprehensive Cancer Center
-
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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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Andra namn:
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Correlation of the acute permeability and blood flow response (24-48 hours) with progression-free survival (PFS)
Tidsram: 1 year
|
Assessed by DCE-MRI
|
1 year
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Overall Survival and Tumor Response
Tidsram: 2 years
|
2 years
|
Incidence and severity of central nervous system (CNS) hemorrhage and systemic hemorrhage
Tidsram: 2 years
|
2 years
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studiestol: James J. Vredenburgh, MD, Duke Cancer Institute
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Sjukdomar i nervsystemet
- Neoplasmer efter histologisk typ
- Neoplasmer
- Neoplasmer efter plats
- Neoplasmer, körtel och epitel
- Neoplasmer, neuroepitelial
- Neuroektodermala tumörer
- Neoplasmer, könsceller och embryonala
- Neoplasmer, nervvävnad
- Gliom
- Neoplasmer i nervsystemet
- Neoplasmer i centrala nervsystemet
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Enzyminhibitorer
- Antineoplastiska medel
- Topoisomerasinhibitorer
- Antineoplastiska medel, immunologiska
- Angiogeneshämmare
- Angiogenesmodulerande medel
- Tillväxtämnen
- Tillväxthämmare
- Topoisomeras I-hämmare
- Bevacizumab
- Irinotekan
Andra studie-ID-nummer
- Pro00012387
- DUMC-8053-05-12R0
- CDR0000481476 (Annan identifierare: NCI)
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