- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00595322
Bevacizumab in the Radiation Treatment of Recurrent Malignant Glioma
Safety of Bevacizumab in the Radiation Treatment of Recurrent Malignant Glioma: A Pilot Study
This is a pilot study. The goal of this study is to test whether Bevacizumab is safe enough in patients with brain tumors so that a larger study can be conducted. This study will also give us some information about whether the combination of Bevacizumab and radiation has potential to become an effective treatment for regrowing brain tumors.
Bevacizumab is an experimental drug that blocks a molecule called VEGF that is found in high amounts in malignant gliomas. VEGF promotes the growth of blood vessels that bring nutrients to tumor cells. In studies with laboratory animals, Bevacizumab slowed the growth of several different types of human cancer cells by blocking the effects of VEGF. There is also evidence that Bevacizumab enhances the effects of radiation on tumor cell
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
New York
-
Commack, New York, Forenede Stater, 11725
- Memorial Sloan-Kettering Cancer Center @ Suffolk
-
New York, New York, Forenede Stater, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Recurrent malignant glioma that has failed prior radiotherapy and/or chemotherapy. Surgery for the recurrence may be offered to selected patients prior to receiving bevacizumab and IMRT on this protocol.
- MRI scan with gadolinium contrast showing geographically-circumscribed tumor < than or equal to 3.5cm. (Scan must be performed on a steroid dosage that has been stable for at least 5 days. If the steroid dose is increased between date of imaging and registration, a new baseline MRI is required).
- Patients must have recovered from the toxic effects of prior therapy:
- An interval of > than or equal to 4 weeks (28 days) from prior cytotoxic therapy
- An interval of > than or equal to 1 week (7 days) from any non-cytotoxic agents
- An interval of > than or equal to 6 weeks (42 days) from the completion of radiation therapy
- Absolute neutrophil count > than or equal to 1,500/mm3.
- Platelet count > than or equal to 100,000/mm3.
- Hemoglobin > than or equal to 10 g/dl.
- BUN and serum creatinine both < 1.5 times upper limit of normal.
- Total bilirubin both < 1.5 times upper limit of normal.
- SGOT and SGPT both < than or equal to 3 times upper limit of normal.
- Alkaline phosphatase < than or equal to 2 times upper limit of normal.
- > than or equal to 18 years of age.
- Karnofsky Performance Score > or equal to 70
- Life expectancy > or equal to 12 weeks
- Men and women with reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment.
- Patient or their legal proxy must provide written informed consent prior to registration on study.
Exclusion Criteria:
- Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study.
- Blood pressure >150 mmHg systolic and/or >100 mmHg diastolic
- Any prior history of hypertensive crisis or hypertensive encephalopathy
- Unstable angina within 12 months of study enrollment
- CTC 3.0 Grade 2 or greater congestive heart failure
- History of myocardial infarction within 12 months of study enrollment
- History of stroke or transient ischemic attack at any time
- Known CNS disease
- Known hypersensitivity to any component of bevacizumab
- History of peptic ulcer within the last 6 months
- Clinically significant peripheral vascular disease
- Evidence of bleeding diathesis or coagulopathy
- Use of ongoing anticoagulants or antiplatelet agents (aspirin, NSAIDS, etc)
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to the first dose of bevacizumab or anticipation of need for major surgical procedure during the course of the study. (Recently resected patients may be enrolled on-study two weeks post-surgery. However, treatment with Bevacizumab will not begin until 28 days after the surgical procedure for all patients.)
- Craniotomy wound that has not sufficiently healed
- Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to study enrollment
- Pregnant (positive pregnancy test) or lactating
- Urine protein:creatinine ratio ≥1.0 at screening
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
- Serious, non-healing wound, ulcer, or bone fracture
- Lung carcinoma of squamous cell histology or any histology in close proximity to a major vessel, cavitation, or history of hemoptysis
- Inability to comply with study and/or follow-up procedures
- Glioma showing prior spontaneous hemorrhage as determined from the clinical history or from any preoperative CT or MRI scan.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 1
bevacizumab and radiation (IMRT)
|
bevacizumab 10 mg/kg IV once every two weeks on days 1 and 15 of every cycle (cycle defined as 28 days).
If the tumor volume remains < 40 cc, the patient will undergo stereotactic radiotherapy with IMRT (30Gy) beginning anywhere from day 7-10 of cycle 2 (5 doses of 6 Gy over 2 and a half weeks)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
To test the safety of bevacizumab in patients with recurrent malignant gliomas in preparation for a larger study to test the efficacy of this drug used during the initial radiation treatment of these tumors if safety is affirmed.
Tidsramme: conclusion of study
|
conclusion of study
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Philip Gutin, MD, Memorial Sloan Kettering Cancer Center
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer efter sted
- Neoplasmer, kirtel og epitel
- Sygdomsegenskaber
- Neoplasmer, Neuroepithelial
- Neuroektodermale tumorer
- Neoplasmer, kimceller og embryonale
- Neoplasmer, nervevæv
- Neoplasmer i centralnervesystemet
- Neoplasmer i nervesystemet
- Tilbagevenden
- Gliom
- Neoplasmer i hjernen
- Lægemidlers fysiologiske virkninger
- Antineoplastiske midler
- Antineoplastiske midler, immunologiske
- Angiogenese-hæmmere
- Angiogenesemodulerende midler
- Vækststoffer
- Væksthæmmere
- Bevacizumab
Andre undersøgelses-id-numre
- 05-092
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Hjernekræft
-
Assistance Publique Hopitaux De MarseilleUkendt
-
National Institute of Mental Health (NIMH)AfsluttetKÆLEDYR | Brain Imaging | Cannabinoid | CB1Forenede Stater
-
Mayo ClinicAfsluttetBrain Imaging | Billedbehandling af hele kroppenForenede Stater
-
GE HealthcareAfsluttetBrain Imaging | Billedbehandling af hele kroppenForenede Stater
-
Tang-Du HospitalIkke rekrutterer endnuPsykisk lidelse | Sociale medier | Brain Imaging
-
University Hospital TuebingenAfsluttetFunktionel dyspepsi | Mad | Brain ImagingTyskland
-
University of MichiganAfsluttetÆndringer i Brain Network ConnectivityForenede Stater
-
School of Health Sciences GenevaUniversity of Lausanne Hospitals; University of Geneva, SwitzerlandRekrutteringMR scanning | Opførsel | Funktionel magnetisk resonansbilleddannelse | Musik | Udvikling, barn | Brain Imaging | Executive funktioner | Hjerneplasticitet | Interventioner | Kunst | Strukturel hjerneforbindelseSchweiz
-
Rigshospitalet, DenmarkLundbeck Foundation; Filadelfia Epilepsy Hospital; Lennart Grams Mindefond...AfsluttetKirurgi | Refraktær epilepsi | Elektroencefalografi | Brain ImagingDanmark
-
Sándor BeniczkyHospital del Mar; Centro Hospitalar e Universitário de Coimbra, E.P.E.; Motol... og andre samarbejdspartnereAktiv, ikke rekrutterendeKirurgi | Refraktær epilepsi | Elektroencefalografi | Brain ImagingSpanien, Portugal, Østrig, Tjekkiet, Danmark, Tyskland, Italien, Rumænien
Kliniske forsøg med bevacizumab and radiation (IMRT)
-
Medical College of WisconsinAktiv, ikke rekrutterendeProstatakræftForenede Stater
-
Memorial Sloan Kettering Cancer CenterNovartis PharmaceuticalsAfsluttetHoved- og nakkepladecellekræftForenede Stater
-
University of Michigan Rogel Cancer CenterNational Institutes of Health (NIH)Aktiv, ikke rekrutterendePlanocellulært karcinom i hoved og halsForenede Stater
-
University of Texas Southwestern Medical CenterTrukket tilbageLokalt avanceret pancreas adenocarcinomForenede Stater, Japan
-
EMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, Germany; GORTEC (Head and Neck Oncology and Radiotherapy...Aktiv, ikke rekrutterendePlanocellulært karcinom i hoved og halsForenede Stater, Spanien, Korea, Republikken, Taiwan, Kina, Argentina, Frankrig, Japan, Israel, Det Forenede Kongerige, Belgien, Tyskland, Portugal, Grækenland, Italien, Georgien, Australien, Tjekkiet, Brasilien, Canada, Østrig, Den... og mere
-
Radiation Therapy Oncology GroupNational Cancer Institute (NCI)AfsluttetVoksen kæmpecelleglioblastom | Voksen glioblastom | Gliosarkom hos voksne | Tilbagevendende voksen hjernetumorForenede Stater
-
Centre Francois BaclesseNational Cancer Institute, FranceRekrutteringStrålebehandling | PARP-hæmmer | Ondartede gliomerFrankrig
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RekrutteringOrofaryngeal cancer | Ondartede neoplasmer i mundhulen i læben og svælgetForenede Stater
-
Ohio State University Comprehensive Cancer CenterAfsluttetHoved- og halskræftForenede Stater
-
Zhejiang Cancer HospitalIkke rekrutterer endnuNasopharyngealt karcinom