- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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New York
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Commack, New York, Stati Uniti, 11725
- Memorial Sloan-Kettering Cancer Center @ Suffolk
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New York, New York, Stati Uniti, 10065
- Memorial Sloan Kettering Cancer Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 1
bevacizumab and radiation (IMRT)
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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)
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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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.
Lasso di tempo: conclusion of study
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conclusion of study
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Philip Gutin, MD, Memorial Sloan Kettering Cancer Center
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Neoplasie per tipo istologico
- Neoplasie
- Neoplasie per sede
- Neoplasie, ghiandolari ed epiteliali
- Attributi della malattia
- Neoplasie, Neuroepiteliali
- Tumori neuroectodermici
- Neoplasie, cellule germinali ed embrionali
- Neoplasie, tessuto nervoso
- Neoplasie del sistema nervoso centrale
- Neoplasie del sistema nervoso
- Ricorrenza
- Glioma
- Neoplasie cerebrali
- Effetti fisiologici delle droghe
- Agenti antineoplastici
- Agenti antineoplastici, immunologici
- Inibitori dell'angiogenesi
- Agenti di modulazione dell'angiogenesi
- Sostanze per la crescita
- Inibitori della crescita
- Bevacizumab
Altri numeri di identificazione dello studio
- 05-092
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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