- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01392209
Hypofractionated Stereotactic Radiotherapy With Bevacizumab in the Treatment of Recurrent Malignant Glioma
20 novembre 2019 mis à jour par: Memorial Sloan Kettering Cancer Center
A PHASE I DOSE ESCALATION STUDY OF HYPOFRACTIONATED STEREOTACTIC RADIOTHERAPY WITH BEVACIZUMAB IN THE TREATMENT OF RECURRENT MALIGNANT GLIOMA
The best dose of radiation to be given with bevacizumab is currently unknown.
This study will use higher doses of radiation with bevacizumab than have been used before.
This study will test the safety of radiation given at different doses with bevacizumab to find out what effects, good and/or bad, it has on the patient and the malignant glioma or related brain cancers.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
15
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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California
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San Francisco, California, États-Unis, 94143
- University of California San Francisco
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New Jersey
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Basking Ridge, New Jersey, États-Unis, 07920
- Memorial Sloan Kettering Basking Ridge
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New York
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Commack, New York, États-Unis, 11725
- Memorial Sloan Kettering Commack
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Harrison, New York, États-Unis, 10604
- Memorial Sloan Kettering Westchester
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New York, New York, États-Unis, 10065
- Memorial Sloan Kettering Cancer Center
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Patients must have EITHER
- Histologically confirmed intracranial malignant glioma of the following types: Glioblastoma, Anaplastic astrocytoma (AA), Anaplastic oligodendroglioma (AO), Anaplastic oligo-astrocytoma (AOA) also called anaplastic mixed gliomas, Malignant glioma NOS (not otherwise specified). Patients will be eligible if the original histology was low-grade glioma and a subsequent histological diagnosis of a high grade (malignant) glioma is made.
OR
- Histologically confirmed low grade (WHO grade II) gliomas (such as low grade astrocytoma, low grade oligodendroglioma, low grade oligo-astrocytoma (mixed gliomas), or low grade glioma NOS) IF there is radiographic evidence by MRI of malignant transformation but histologic confirmation of high grade (malignant) transformation would not be otherwise undertaken for routine clinical care. Inclusion of patients in this group will allow increased accrual rapidity by enrolling patients who are otherwise ineligible for almost all malignant glioma trials yet whom are treated presumptively for malignant glioma. The primary aim of the phase I study is not determination of efficacy. Therefore, inclusion of such patients will not affect efficacy analyses.
Participating site confirmation is adequate.
- Able to undergo brain MRI scans.
- MRI scan with gadolinium contrast showing geographically-circumscribed tumor ≤40 cc incorporating both enhancing and non-enhancing volume. This is calculated by the product of maximum measurements in 3 dimensions divided by 2. Tumors exceeding this limit may be eligible and any question should be directed to a Radiation Oncology Investigator and the MSK PI. (The MRI must be performed on a steroid dosage that has been stable or decreasing for at least 5 days. Patients on no steroids are eligible. If the steroid dose is increased between date of imaging and registration, a new baseline MRI is required).
- Prior treatment with approximately 60 Gy of radiotherapy.
- Patients must have recovered from the toxic effects of prior therapy including but not limited to:
- An interval of ≥ 4 weeks (28 days) from prior cytotoxic therapy except 6 weeks from nitrosoureas
- An interval of ≥ 1 week (7 days) from any non-cytotoxic agents
- An interval of ≥ 3 months from the completion of radiation therapy
- Absolute neutrophil count ≥ 1,500/mm3.
- Platelet count ≥ 100,000/mm3.
- Hemoglobin ≥ 10 g/dl.
- Serum creatinine ≤ 2 times upper limit of normal.
- Total bilirubin ≤ 2 times upper limit of normal.
- SGOT and SGPT both ≤ 3 times upper limit of normal.
- ≥18 years of age.
- Karnofsky Performance Score ≥ 60
- Life expectancy ≥ 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.
- Written informed consent prior to registration on study.
Exclusion Criteria:
- Prior treatment with radiosurgery
- Prior disease progression/recurrence during or immediately following treatment with bevacizumab. Any question should be directed to the PI.
- Multicentric glioma
- Other malignancy (with the exception of cervical carcinoma in situ or basal cell carcinoma of the skin) for which there has been treatment within the last 3 years
- Serious medical or psychiatric illness that would in the opinion of the investigator interferes with the prescribed treatment.
- Pregnant or breast feeding women
- Inadequately controlled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure > 100 mmHg)
- Any prior history of hypertensive crisis or hypertensive encephalopathy
- Grade 2 or greater congestive heart failure
- History of myocardial infarction, unstable angina, stroke, or transient ischemic attack within 12 months prior to Day 1
- Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1
- History of hemoptysis ≥1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1
- Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 of treatment or anticipation of need for major surgical procedure during the course of the study
- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1
- Serious, non-healing wound, active ulcer, or untreated bone fracture
- Proteinuria as demonstrated by a UPC ratio ≥ 1.0 at screening
- Known hypersensitivity to any component of bevacizumab
- History of peptic ulcer within the last 6 months
- Clinically significant peripheral vascular disease
- Craniotomy wound that has not sufficiently healed
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
- Glioma showing prior spontaneous hemorrhage as determined from the clinical history or from any preoperative CT or MRI scan (excluding grade 1 punctate, incidentally found).
- Longest uni-dimensional measurement of contrast enhancing tumor ≥ 4cm. Tumors exceeding this limit may be eligible and any question should be directed to a Radiation Oncology Investigator and the MSK PI.
- Tumor must not invade the corpus callosum
- Tumor must not invade the brainstem
- Suspected or documented radionecrosis
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Bevacizumab & Stereotactic Radiotherapy
This will be a multicenter (MSKCC and UCSF) phase I dose escalation study to determine the maximum tolerated dose (MTD) of hypofractionated stereotactic radiotherapy when administered in combination with a fixed dose of bevacizumab.
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Treatment: (until treatment failure): bevacizumab 10 mg/kg IV once every two weeks on days 1 (+/- 3 days) and 15 (+/- 3 days) of every cycle (Cycle defined as 28 days).
On day 28 (or up to 2 days before) of cycles 1 and 2 (and for every other cycle thereafter) patients will undergo a physical and radiological re-evaluation (MRI).
Patients will begin stereotactic radiotherapy beginning anywhere from day 7 to day 10 of cycle 2 with escalating fraction sizes (interpatient - there is no intrapatient escalation).
Assessment of response will be performed following cycles 1 and 2 then following every two cycles.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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To establish the maximum tolerated dose (MTD)
Délai: 1 year
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of hypofractionated stereotactic re-irradiation delivered with concomitant bevacizumab in recurrent malignant gliomas (using a standard 3+3 design).
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1 year
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Response rate
Délai: 1 year
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Median overall survival and progression-free survival, along with the estimated survival and PFS rates at specified time points will be estimated using Kaplan-Meier method.
Confidence intervals will be included with all point estimates.
Response rate will be estimated using an exact binomial distribution together with 95% confidence interval.
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1 year
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Median progression free survival
Délai: 1 year
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Median overall survival and progression-free survival, along with the estimated survival and PFS rates at specified time points will be estimated using Kaplan-Meier method.
Confidence intervals will be included with all point estimates.
Response rate will be estimated using an exact binomial distribution together with 95% confidence interval.
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1 year
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6 month progression-free survival rate
Délai: 1 year
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Median overall survival and progression-free survival, along with the estimated survival and PFS rates at specified time points will be estimated using Kaplan-Meier method.
Confidence intervals will be included with all point estimates.
Response rate will be estimated using an exact binomial distribution together with 95% confidence interval.
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1 year
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Median overall survival
Délai: 1 year
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Median overall survival and progression-free survival, along with the estimated survival and PFS rates at specified time points will be estimated using Kaplan-Meier method.
Confidence intervals will be included with all point estimates.
Response rate will be estimated using an exact binomial distribution together with 95% confidence interval.
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1 year
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Use of tractography to predict routes of progression in gliomas (MSKCC only)
Délai: 1 year
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DTI will be acquired at the time of the patient's routinely scheduled brain MRIs but at least on the baseline scan and the MRI 1 month after cycle 2. DTI parameters: A spin-echo echo-planar sequence using 25 gradient directions, TR/TE 11000/100 msec; matrix 128 × 128; in-plane resolution 1.88 × 1.88 mm; slice thickness 3 mm; b-value 1000 sec/mm2; NEX 1 and maximum diffusion gradient strength 22mTm-1.
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1 year
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Correlation of VEGF and VEGFR IHC and related pathways (MSKCC only) and MGMT promoter methylation with efficacy
Délai: 1 year
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Exploratory analyses related to VEGFR signaling including IHC for VEGF and VEGFR on pre-treatment tissue and post-treatment tissue and the analysis of biological correlate data has the overall goal of providing increased understanding of the nature of the response to bevacizumab but the amount of data available for the various measures is uncertain.
Information may also be limited by the impact of intervening treatment between the most recent surgery and initiation of study treatment.
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1 year
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
8 juillet 2011
Achèvement primaire (Réel)
15 novembre 2019
Achèvement de l'étude (Réel)
15 novembre 2019
Dates d'inscription aux études
Première soumission
8 juillet 2011
Première soumission répondant aux critères de contrôle qualité
11 juillet 2011
Première publication (Estimation)
12 juillet 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
22 novembre 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
20 novembre 2019
Dernière vérification
1 novembre 2019
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Tumeurs par type histologique
- Tumeurs
- Tumeurs par site
- Tumeurs, glandulaires et épithéliales
- Tumeurs, neuroépithéliales
- Tumeurs neuroectodermiques
- Tumeurs, cellules germinales et embryonnaires
- Tumeurs, tissu nerveux
- Tumeurs du système nerveux central
- Tumeurs du système nerveux
- Glioblastome
- Gliome
- Tumeurs cérébrales
- Astrocytome
- Oligodendrogliome
- Effets physiologiques des médicaments
- Agents antinéoplasiques
- Agents antinéoplasiques immunologiques
- Inhibiteurs de l'angiogenèse
- Agents modulateurs de l'angiogenèse
- Substances de croissance
- Inhibiteurs de croissance
- Bévacizumab
Autres numéros d'identification d'étude
- 11-057 (Identificateur de registre: ROCTR)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Bevacizumab & Stereotactic Radiotherapy
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Jona Hattangadi-GluthNational Cancer Institute (NCI); National Institutes of Health (NIH)RecrutementCancer | Métastases cérébrales, adulte | Fonction neurocognitiveÉtats-Unis
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Dana-Farber Cancer InstituteBristol-Myers Squibb; Genentech, Inc.Complété
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Koen RoversHoffmann-La Roche; Comprehensive Cancer Centre The Netherlands; Dutch Cancer...RecrutementCancer colorectal | Tumeurs péritonéales | Tumeur colorectale | Carcinose péritonéale | Carcinome colorectal | Cancer péritonéal | Métastases péritonéales | Adénocarcinome colorectal | Tumeurs colorectales malignes | Tumeur péritonéale Carcinomatose secondaire maligne | Tumeur péritonéale maligne secondairePays-Bas, Belgique
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National Cancer Institute (NCI)Actif, ne recrute pasCarcinome récurrent des trompes de Fallope | Carcinome ovarien récurrent | Carcinome péritonéal primitif récurrent | Cystadénocarcinome à cellules claires de l'ovaire | Adénocarcinome endométrioïde ovarien | Cystadénocarcinome séreux ovarien | Adénocarcinome à cellules claires de l'endomètre | Adénocarcinome... et d'autres conditionsÉtats-Unis
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Harbin Medical UniversitySun Yat-sen University; Fudan University; Cancer Institute and Hospital, Chinese... et autres collaborateursInconnueTumeurs colorectales | ChimiothérapieChine
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Hoffmann-La RocheComplétéGlioblastome multiformeSuisse, France, Royaume-Uni, Danemark
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Spanish Cooperative Group for the Treatment of...Roche Pharma AGComplété
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.ComplétéCancer du col de l'utérus | Glioblastome | Cancer des ovaires | Cancer du poumon | Cancer rectalChine
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Azienda Ospedaliero, Universitaria PisanaComplété
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National Taiwan University HospitalRésilié