- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00800917
A Study of Temsirolimus and Bevacizumab in Recurrent Glioblastoma Multiforme
A Phase II Study of Temsirolimus and Bevacizumab in Recurrent Glioblastoma Multiforme
This trial is an investigator initiated, open label phase II study, where patient with recurrent primary GBM will be considered for the study. Only patients with recurrence after Temozolomide and VEGF-directed therapy with Bevacizumab will be considered for the study. Patients will receive temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15 and 22 and bevacizumab 10 mg/kg IV over 30-90 minutes on day 8 and 22. Treatment repeats every 28 days for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity. A safety analysis will be performed when the first 10 patients have received minimum 4 cycles (8 weeks). The study will then be stopped:
If DLT is observed in > 2/10 patients, Occurrence of any serious adverse events not described in the SPC of each agents, If partial remission is not observed in at least 1/10 patients
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
-
Copenhagen, Danmark
- Rigshospitalet
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Written informed consent
- Histological verification of primary GBM and failure after radiotherapy and temozolomide (TMZ)
- Previously treated with VEGF-directed therapy with bevacizumab
- Previously received radiotherapy and temozolomide
- More than 4 weeks since any of the following prior treatments: chemotherapy (6 weeks for nitrosoureas or mitomycin C)
- Radiotherapy to nontarget lesions or lesions that are not to be biopsied VEGF-directed therapy (including bevacizumab)
- Investigational agents
- More than 6 months since prior major surgery or open biopsy and recovered (only 6 weeks required if operation is for recurrent GBM)
No concurrent medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of the following:
- Temsirolimus
- Bevacizumab
- CYP450 isoenzymes
- ECOG performance status 0-1
- WBC ≥ 3,000 mm³
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Bilirubin and phosphate normal
- AST and ALT ≤ 2.5 times upper limit of normal
- Creatinine normal OR creatinine clearance ≥ 60 mL/min
- Urine protein: creatinine ratio < 1.0 OR 24-hour urine protein < 1,000 mg
- Fasting cholesterol < 350 mg/dL (cholesterol medications are allowed)
- Fasting triglycerides < 400 mg/dL
- PT INR ≤ 1.5
- Hematocrit < 41% (for males) or < 38% (for females)
- Fertile females must use an approved contraceptive (p-pills, IUD, depot injection of gestagen, subdermal implantation, hormonal vaginal ring or transdermal depot plaster), throughout the study and 3 months after discontinuation of study drugs. Fertile men must use dobbelt barrier method (preservative with sperm inhibiting creme) or female partner uses the above mentioned contraceptive.
- Fertile males must use preservatives.
Exclusion Criteria:
- Clinically significant cardiovascular disease, including the following:
- Cerebrovascular accident within the past 6 months
- Transient ischemic attack within the past 6 months
- Myocardial ischemia within the past 6 months
- Myocardial infarction within the past 6 months
- Other thromboembolic event within the past 6 months
- Unstable angina within the past 6 months
- Uncontrolled hypertension (i.e., hypertension despite maximal therapy)
- New York Heart Association class II-IV heart disease
- Congestive heart failure
- Serious cardiac arrhythmia requiring medication
- Clinically significant peripheral vascular disease
- Uncontrolled intercurrent illness
- Ongoing or active infection
- One of the following within the past 6 months
- Abdominal fistula
- Gastrointestinal perforation
- Intra-abdominal abscess
- Serious or nonhealing wound, ulcer, or bone fracture
- Psychiatric illness or social situations that would preclude study compliance
- Uncontrolled diabetes
- Hemoglobin A1c > 7%
- Concurrent non-study related surgical procedures
- Concurrent treatment with CYP3A4 inducers or inhibitors
- Other concurrent anticancer agents or therapies
- Significant traumatic injury within the past 28 days
- History of allergic reactions to compounds of similar chemical or biological composition to temsirolimus or bevacizumab
- Hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies (e.g., infliximab)
- Pregnancy or nursing
- Patients previously intolerant to bevacizumab
- Anticoagulant therapy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Progression-free survival in months
Tidsramme: From start of treatment to death or progression
|
From start of treatment to death or progression
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Adverse events
Tidsramme: every 2 weeks
|
every 2 weeks
|
Objective tumor response rate
Tidsramme: every 8 weeks
|
every 8 weeks
|
Pre- vs post-treatment measurements of biomarkers and vascular system/immune system parameters
Tidsramme: weekly for the first 4 weeks, then every 8 weeks
|
weekly for the first 4 weeks, then every 8 weeks
|
Correlation with biomarkers
Tidsramme: at the end of the study
|
at the end of the study
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
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 (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer, kirtel og epitel
- Astrocytom
- Gliom
- Neoplasmer, Neuroepithelial
- Neuroektodermale tumorer
- Neoplasmer, kimceller og embryonale
- Neoplasmer, nervevæv
- Glioblastom
- Lægemidlers fysiologiske virkninger
- Anti-infektionsmidler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antineoplastiske midler, immunologiske
- Angiogenese-hæmmere
- Angiogenesemodulerende midler
- Vækststoffer
- Væksthæmmere
- Antibakterielle midler
- Antibiotika, antineoplastisk
- Antifungale midler
- Bevacizumab
- Sirolimus
Andre undersøgelses-id-numre
- BEV-CCI-779-GBM-02
- Eudract no.: 2008-003679-40
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 Glioblastoma Multiforme
-
Stony Brook UniversityGarnett McKeen Laboratory Inc.AfsluttetGlioblastoma multiform (grad IV astrocytom)Forenede Stater
-
Royan InstituteTehran University of Medical SciencesRekrutteringTilbagevendende glioblastom | Glioblastoma MultiformIran, Islamisk Republik
-
Milton S. Hershey Medical CenterRekrutteringGlioblastom | Glioblastoma Multiforme | Glioblastoma Multiforme, voksen | Glioblastoma Multiforme i hjernenForenede Stater
-
Milton S. Hershey Medical CenterNational Cancer Institute (NCI)RekrutteringGlioblastom | Glioblastoma Multiforme | Glioblastoma Multiforme, voksen | Glioblastoma Multiforme i hjernenForenede Stater
-
Jasper GerritsenMassachusetts General Hospital; Universitaire Ziekenhuizen KU Leuven; University... og andre samarbejdspartnereRekrutteringGlioblastom | Glioblastoma Multiforme | Glioblastom, IDH-vildtype | Glioblastoma Multiforme, voksen | Glioblastoma Multiforme i hjernenForenede Stater, Belgien, Schweiz, Tyskland, Holland
-
University of UtahTrukket tilbageGlioblastoma Multiforme (GBM)Forenede Stater
-
TVAX BiomedicalFDA Office of Orphan Products DevelopmentRekrutteringGlioblastoma Multiforme i hjernenForenede Stater
-
Shenzhen Geno-Immune Medical InstituteTilmelding efter invitationGlioblastoma Multiforme | Glioblastoma Multiforme i hjernenKina
-
University of Roma La SapienzaAfsluttetGlioblastoma Multiforme i hjernen
-
Imperial College LondonRekrutteringGlioblastoma Multiforme i hjernenDet Forenede Kongerige
Kliniske forsøg med Temsirolimus
-
Sheba Medical CenterStanley Medical Research InstituteUkendtSkizofreni | Skizoaffektiv lidelseIsrael
-
St. Joseph's Healthcare HamiltonPfizer; McMaster UniversityAfsluttet
-
New Mexico Cancer Care AllianceWyeth is now a wholly owned subsidiary of PfizerAfsluttetSarkomForenede Stater
-
AVEO Pharmaceuticals, Inc.Afsluttet
-
Dana-Farber Cancer InstituteWyeth is now a wholly owned subsidiary of Pfizer; Millennium Pharmaceuticals...Afsluttet
-
Children's Hospital Medical Center, CincinnatiTrukket tilbageLymfom, B-celle | Leukæmi, B-celleForenede Stater
-
Goethe UniversityAfsluttetAkut myeloblastisk leukæmiTyskland
-
Mathias Witzens-HarigCharite University, Berlin, Germany; Ludwig-Maximilians - University of... og andre samarbejdspartnereUkendtDiffust storcellet B-celle lymfomTyskland
-
Wyeth is now a wholly owned subsidiary of PfizerPfizerAfsluttetBrystneoplasmer
-
M.D. Anderson Cancer CenterAfsluttet