NCT02065466撤回1 期
A Pilot Study of the Combination of Nab-paclitaxel, Temozolomide and Bevacizumab in Patients With Metastatic Melanoma With Brain Metastases
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Maximum Tolerance Dose
研究概览
简要总结
1.1. Primary Objectives
- To determine if nab-paclitaxel and temozolomide can be combined with full dose of bevacizumab for the therapy of patients with newly diagnosed brain metastases of metastatic malignant melanoma.
- To define the MTD of the combination (Phase I component).
- To determine progression free survival (Phase II component). 1.2. Secondary Objectives
- To separately evaluate the response rate and duration of both the brain and extra-cranial systemic metastases.
- To define the toxicity of the regimen.
- To tabulate the toxicity of the radiotherapy to the brain and compare with known toxicities of radiotherapy to the brain in melanoma and brain metastases.
- To use the data generated to plan definitive controlled clinical trials of the combination.
- To determine the overall response rate (Phase II component).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed malignant melanoma and clinical evidence of metastatic disease to the brain. Mucosal and ocular melanomas are included.
- •Newly developed inoperable brain metastases without associated hemorrhage or midline shift.
- •Inoperable or metastatic extra cranial stage III or IV disease.
- •Diagnostic quality MRI of the brain or if contraindicated then contrast CT scan of the head performed within 28 days prior to registration.
- •Measurable metastases to the brain, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >10 mm in the brain MRI/CT scan.
- •CT scan chest, abdomen and pelvis or PET CT scan performed within 28 days of study registration. For disease outside the brain, tumors must be > 10 mm by CT scan.
- •Prior therapy allowed but no prior therapy with nab-paclitaxel, paclitaxel, temozolomide, DTIC or bevacizumab.
- •Bevacizumab may not be initiated until 4 weeks after surgical resection or radiation therapy completion.
- •Age 18 or older.
- •Pre-existing peripheral neuropathy must have < Grade 2 (per CTCAE 4.0) at the time of registration.
- •Negative serum or urine β-hCG pregnancy test at screening for patients of childbearing potential.
- •Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment.
- •ECOG Performance status 0-
- •Estimated life expectancy of greater than 2 months.
- •Patients must have adequate organ function as defined below (these must be evaluated within 14 days prior to registration):
- •leukocytes >3,000/mcL
- •absolute neutrophil count >1,500/mcL
- •platelets >100,000/mcL
- •Hemoglobin >9.0 g/dL
- •AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit
- •Alkaline phosphatase <2.5 X institutional upper limit
- •Total bilirubin <1.5 X institutional upper limit of normal (unless associated with Gilbert's syndrome)
- •serum creatinine < 1.5 mg/dL OR 1.5 x institutional normal
- •LDH there is no restriction
- •INR <1.5 PTT WNL
- •Urine protein (UPC) ratio 1.0 OR
- •Urine dipstick for proteinuria. Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible).
- •Able to render informed consent.
排除标准
- •Prior surgical resection for brain metastases.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab, nab-paclitaxel or temozolomide.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics, symptomatic congestive heart failure, unstable angina pectoris, untreated cardiac arrhythmia and peripheral vascular disease.
- •History of myocardial infarction or unstable angina within 6 months prior to Day
- •History of stroke or transient ischemic attack within 6 months prior to Day
- •History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study screening.
- •Serious, non-healed wound, ulcer, or bone fracture.
- •History of hepatitis B, C or HIV.
- •Uncontrolled hypertension or chronic renal disease. No known bleeding diathesis.
- •Known hypersensitivity to human albumin.
- •Surgery within 4 weeks of study registration. Must be fully recovered and fully healed from any prior surgery.
- •Patients having chemotherapy or extra cranial radiotherapy within 4 weeks prior to study screening or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to the completion of study screening.
- •Evidence of other concurrent active malignancy.
- •Pregnant or nursing.
- •Not be receiving any other investigational agent.
研究组 & 干预措施
Combination
Experimental
nab-paclitaxel and temozolomide combined with full dose of bevacizumab
干预措施: Bevacizumab (Drug)
Combination
Experimental
nab-paclitaxel and temozolomide combined with full dose of bevacizumab
干预措施: nab-paclitaxel (Drug)
Combination
Experimental
nab-paclitaxel and temozolomide combined with full dose of bevacizumab
干预措施: Temozolomide (Drug)
结局指标
主要结局
Maximum Tolerance Dose
时间窗: Beginning of Treatment to unstable disease or discontinuation (6 months)
To define the MTD of the combination (Phase I component).
Progression Free Survival
时间窗: Treatment to End of Follow-up (6 Months)
To determine progression free survival (Phase II component).
次要结局
- Response Rate(Baseline to end of follow-up (six months))
研究者
研究点 (2)
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