- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01392209
Hypofractionated Stereotactic Radiotherapy With Bevacizumab in the Treatment of Recurrent Malignant Glioma
20 de novembro de 2019 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
15
Estágio
- Fase 1
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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California
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San Francisco, California, Estados Unidos, 94143
- University of California San Francisco
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New Jersey
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Basking Ridge, New Jersey, Estados Unidos, 07920
- Memorial Sloan Kettering Basking Ridge
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New York
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Commack, New York, Estados Unidos, 11725
- Memorial Sloan Kettering Commack
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Harrison, New York, Estados Unidos, 10604
- Memorial Sloan Kettering Westchester
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New York, New York, Estados Unidos, 10065
- Memorial Sloan Kettering Cancer Center
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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To establish the maximum tolerated dose (MTD)
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Response rate
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 1 year
|
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)
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Links úteis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
8 de julho de 2011
Conclusão Primária (Real)
15 de novembro de 2019
Conclusão do estudo (Real)
15 de novembro de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
8 de julho de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
11 de julho de 2011
Primeira postagem (Estimativa)
12 de julho de 2011
Atualizações de registro de estudo
Última Atualização Postada (Real)
22 de novembro de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
20 de novembro de 2019
Última verificação
1 de novembro de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças Cerebrais
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Neoplasias por Tipo Histológico
- Neoplasias
- Neoplasias por local
- Neoplasias Glandulares e Epiteliais
- Neoplasias Neuroepiteliais
- Tumores Neuroectodérmicos
- Neoplasias, Células Germinativas e Embrionárias
- Neoplasias, Tecido Nervoso
- Neoplasias do Sistema Nervoso Central
- Neoplasias do Sistema Nervoso
- Glioblastoma
- Glioma
- Neoplasias Cerebrais
- Astrocitoma
- Oligodendroglioma
- Efeitos Fisiológicos das Drogas
- Agentes Antineoplásicos
- Agentes Antineoplásicos Imunológicos
- Inibidores de angiogênese
- Agentes Moduladores da Angiogênese
- Substâncias de crescimento
- Inibidores de crescimento
- Bevacizumabe
Outros números de identificação do estudo
- 11-057 (Identificador de registro: ROCTR)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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