- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00884598
Cilengitide and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases From Lung Cancer (CIRAB)
Cilengitide (EMD121974) in Combination With Whole Brain Radiotherapy in Patients With Brain Metastases From Lung Cancer - a Single-center, Open-label Phase I Study
RATIONALE: Cilengitide may stop the growth of brain metastases by blocking blood flow to the tumor. Radiation therapy uses high energy X-rays to kill tumor cells. Giving cilengitide together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of cilengitide when given together with whole-brain radiation therapy in treating patients with brain metastases from lung cancer.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
OBJECTIVES:
Primary
- To assess the safety and tolerability of daily cilengitide by determining its dose-limiting toxicity and maximum-tolerated dose when combined with concomitant fractionated whole-brain radiation therapy in patients with brain metastases from lung cancer.
Secondary
- To collect evidence of the best overall response rate, overall survival, brain-specific progression-free survival, and tumor-specific progression-free survival of these patients.
- To collect evidence of changes in functional MRI imaging studies at 6 and 12 weeks after initiation of therapy.
- To collect evidence of early response by functional MRI (ASL technique) on days 1, 4, and 12, immediately before and after the administration of cilengitide.
- To collect evidence of changes in neurological and neurocognitive function tests at 6 and 12 weeks after initiation of therapy.
- To further evaluate the safety and toxicity of the combination of cilengitide and whole-brain radiation therapy.
- To further evaluate the pharmacokinetics of cilengitide administered daily.
OUTLINE:
Patients receive oral cilengitide once daily and undergo whole-brain radiotherapy on the same days. Treatment continues for 2 weeks in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample collection on days 1, 4, 5, and 12 for pharmacokinetic studies.
After completion of study treatment, patients are followed for 10 weeks.
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 1
Kontakter och platser
Studieorter
-
-
-
Mannheim, Tyskland, D-68167
- Rekrytering
- University Medical Center, Department of Surgery
-
Kontakt:
- Christian Manegold, MD
- Telefonnummer: 49-621-383-2199
- E-post: prof.manegold@t-online.de
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
DISEASE CHARACTERISTICS:
- Histologically confirmed lung cancer (small cell or non-small cell lung cancer)
- Patient must be eligible for whole-brain radiotherapy
- Presence of brain metastasis (single or multiple, synchronous or metachronous) from lung cancer not amenable to surgery or radiosurgery (presence of metastases at any other site is allowed)
- No leptomeningeal metastasis or known subarachnoid spread of tumor
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-1 (ECOG PS 2 allowed if due to the presence of cerebral metastases and not due to a high peripheral-tumor load or other reasons)
- Life expectancy ≥ 3 months
- Adequate hematologic function
- Total bilirubin < 1.5 times upper limit of normal (ULN)
- AST, ALT, and alkaline phosphatase < 2.5 times ULN
- Creatinine clearance > 60 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after completion of study treatment
- No history of acute or chronic renal disease
- No other malignancies treated within the past 5 years, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin
- No uncontrolled hypertension
- No history of coagulation disorder associated with bleeding or recurrent thrombotic events
- No peptic ulcer disease within the past 6 months
- No congestive heart failure, high risk for uncontrolled arrhythmia, or history of clinically significant coronary heart disease
- No known alcohol or drug abuse
- No other significant or acute concomitant disease
- No dementia or altered mental status
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Concurrent corticosteroids allowed if the dosing regimen has ben stable ≥ 5 days
- Concurrent anticonvulsants allowed if the dosing regimen has been stable for the past week
- More than 30 days since prior participation in another clinical trial
- No concurrent anticoagulation with vitamin K antagonists, therapeutic-dose anticoagulation with heparin resulting in prolonged PTT, or therapeutic-dose anticoagulation with low molecular weight heparin (low-dose [i.e. prophylactic], low molecular weight heparins allowed)
- No prior whole-brain radiation or radiosurgery
- No prior antiangiogenic therapy
- No other concurrent anticancer therapy
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Maskning: Ingen (Open Label)
Vad mäter studien?
Primära resultatmått
Resultatmått |
---|
Maximal tolererad dos
|
Dosbegränsande toxicitet
|
Sekundära resultatmått
Resultatmått |
---|
Total överlevnad
|
Total svarsfrekvens
|
Brain-specific progression-free survival (PFS)
|
Tumor-specific PFS
|
Changes in functional MRI imaging studies at 6 and 12 weeks
|
Evidence of early response by functional MRI on days 1, 4, and 12
|
Changes of neurological and neurocognitive function tests at 6 and 12 weeks
|
Safety and toxicity of the combination of cilengitide and whole-brain radiation therapy
|
Pharmacokinetics of cilengitide
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Christian Manegold, MD, University Medical Center Mannheim
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
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
Andra studie-ID-nummer
- CDR0000636508
- HUMCM-CIRAB
- EUDRACT-2008-004573-17
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Lungcancer
-
Chang Gung Memorial HospitalAvslutad
-
University of ZurichDeep Breath Intelligence (DBI)RekryteringLung-/luftvägssjukdomarSchweiz
-
424 General Military HospitalAvslutad
-
Celularity IncorporatedAvslutadSteg 2 Lung sarkoidos | Steg 3 Lung sarkoidosFörenta staterna
-
Tuberculosis Research Centre, IndiaInternational Union Against Tuberculosis and Lung Diseases; Sarvodaya Charitable... och andra samarbetspartnersAktiv, inte rekryterandePre-extensivt läkemedelsresistent lung-TB | Behandling Intolerant multiresistent lung-TB | Icke-responsiv multiresistent lung-TBIndien
-
Centre Hospitalier Universitaire, AmiensAvslutadHemodialyskomplikation | Lung ultraljudFrankrike
-
Papa Giovanni XXIII HospitalAvslutadLungtransplantation | Ex Vivo Lung PerfusionItalien
-
Pontificia Universidad Catolica de ChileRekryteringLung ultraljud | Öppen bukkirurgiChile
-
University Hospital, LilleAvslutad
-
University of Colorado, DenverChildren's Hospital Colorado; Food and Drug Administration (FDA)AvslutadHypertoni;Lung;PrimärFörenta staterna
Kliniska prövningar på farmakologisk studie
-
Tampere University HospitalAvslutad
-
Radicle ScienceAktiv, inte rekryterandeKognitiv funktionFörenta staterna
-
University of MichiganAvslutad
-
Scion NeuroStimAnmälan via inbjudanParkinsons sjukdom | Parkinsons sjukdom och ParkinsonismFörenta staterna
-
Apple Inc.Stanford UniversityAvslutadFörmaksflimmer | Arytmier, hjärt | FörmaksfladderFörenta staterna
-
Boston Scientific CorporationAvslutadVentrikulär takykardiAustralien
-
Radicle ScienceRekryteringSmärta | Neuropatisk smärta | Nociceptiv smärtaFörenta staterna
-
Radicle ScienceAktiv, inte rekryterandePåfrestning | ÅngestFörenta staterna
-
Brock UniversityDairy Farmers of CanadaAvslutadFetma | Övervikt | BarnKanada