临床试验/NCT00326872

NCT00326872终止2 期

A Phase II Study of AZD2171 in Adult Patients With Neurofibromatosis Type 1 and Extensive Plexiform and Paraspinal Neurofibromas

National Cancer Institute (NCI)9 个研究点分布在 1 个国家目标入组 26 人开始时间: 2006年5月最近更新: 2017年8月18日

适应症

干预措施

试验速览

阶段: 2 期
状态: 终止
发起方: National Cancer Institute (NCI)
入组人数: 26
试验地点: 9
主要终点: Proportion of Patients With Tumor Response (Complete Response [CR] or Partial Response [PR])

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This phase II trial is studying how well AZD2171 works in treating patients with neurofibromatosis type 1 and plexiform neurofibroma and/or neurofibroma near the spine. AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

详细描述

PRIMARY OBJECTIVES:

I. Assess the efficacy of AZD2171, in terms of volume change in target tumors by 3-dimensional magnetic resonance imaging (3D MRI).

II. Describe and define the toxicities of AZD2171 in these patients.

SECONDARY OBJECTIVES:

I. Assess the value of 3D MRI data analysis in evaluating plexiform or paraspinal neurofibromas compared to conventional 2-dimensional MRI data analysis.

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

•Diagnosis* of neurofibromatosis type 1 (NF1) and extensive plexiform and/or paraspinal neurofibromasproducing pain (not controlled by use of over-the-counter medications), progressive neurologic deficit, or significant neurologic consequenceswith continuous tumor growth
•Extensive paraspinal neurofibroma defined as a neurofibroma that involves multiple neural roots at ≥ 3 spinal levels with connection between the levels or extending laterally along the nerves
•Symptomatic neurofibromas at < 3 spinal levels, but surgical treatment is not possible, allowed
•Meets ≥ 2 diagnostic criteria for NF1, including the following:
•Six or more café-au-lait spots (≥ 1.5 cm in postpubertal patients)
•Freckling in the axilla or groin
•Optic glioma
•Two or more Lisch nodules
•Distinctive bony lesion (dysplasia of the sphenoid bone or dysplasia orthinning of long-bone cortex)
•First-degree relative with NF1
•Patients with documented mutation in neurofibromin gene with onlysymptomatic plexiform and/or paraspinal neurofibroma who do not fulfill the above clinical criteria are eligible
•Measurable disease, defined as ≥ 1 lesion whose longest diameter can beaccurately measured as 8.0 cm^3 with 3-dimensional (3D) MRI
•Skin lesions are consideredmeasurable (e.g., plexiform neurofibromas), but MRI imaging still required for 3D measurement
•Patients with symptomatic neurofibroma, in whom surgery is not feasible, who refuse surgery or are not goodsurgical candidates due to high risk of damage to vital structures or spinal cordinjury are eligible
•No evidence of progressive optic glioma, malignant glioma, malignant peripheralnerve sheath tumor, or other cancer requiring treatment with chemotherapy orradiotherapy
•ECOG performance status 0-3
•WBC ≥ 3,000/mm^3
•Absolute neutrophil count ≥ 1,500/mm^3
•Platelet count ≥ 100,000/mm^3
•Hemoglobin ≥ 8.0 g/dL
•Bilirubin normal (patients with Gilbert's syndrome allowed despite elevated bilirubin)
•Alkaline phosphatase normal
•AST and ALT ≤ 2.5 times upper limit of normal
•Thyroid-stimulating hormone and free thyroxin normal
•Creatinine normal OR creatinine clearance ≥ 60 mL/min
•Ejection fraction ≥ 50% by echocardiogram
•Not pregnant or nursing
•Negative pregnancy test
•Fertile patients must use effective contraception
•No other uncontrolled, serious medical condition that would preclude study participation, including any of the following:
•Cardiac arrhythmia
•Serious infection
•Significant cardiac, pulmonary, hepatic, or other organ dysfunction
•No psychiatric illness or social situation that would preclude study compliance
•No history of allergic reactions attributed to compounds of similar chemical orbiologic composition to AZD2171
•No New York Heart Association class III or IV disease
•Class II disease controlled with treatment and increased monitoring allowed
•No systolic blood pressure (BP) > 130 mm Hg and diastolic BP > 90 mm Hg
•No history of familial long QT syndrome
•Mean QTc ≤ 470 msec (with Bazett's correction) by EKG
•QTc prolongation ≤ 500 msec
•No other significant ECG abnormality within the past 14 days
•See Disease Characteristics
•More than 30 days since prior investigational agents
•More than 4 weeks since prior radiotherapy, chemotherapy, hormonal therapy directed at thetumor, immunotherapy, biologic therapy (e.g., interferon), or majorsurgery
•No concurrent medication that may markedly affect renal function (e.g., vancomycin, amphotericin, or pentamidine)
•No concurrent CYP interactive medications
•No concurrent combination antiretroviral therapy for HIV-positive patients
•No concurrent enzyme-inducing anticonvulsants (e.g., phenytoin, carbamazepine, or phenobarbital)
•No concurrent use of drugs or biologics with proarrhythmic potential

排除标准

未提供

研究组 & 干预措施

Treatment (cediranib maleate)

Experimental

Patients receive oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, prior to course 2, prior to course 4, and every 6 courses thereafter.

干预措施: Cediranib Maleate (Drug)

结局指标

主要结局

Proportion of Patients With Tumor Response (Complete Response [CR] or Partial Response [PR])

时间窗: Baseline to end of treatment, maximum of 26 cycles (28 days/cycle).

Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the volume of target lesions taking as reference the baseline volume.

次要结局

Survival Time as Measured Using Kaplan-Meier Method(From registration to death (due to any cause) max 51 months)
Duration of Response as Assessed Using the Method of Kaplan-Meier(From time of confirmed tumor objective response as CR or PR to the date of progression max 51 months)
Reduction in Self Reported Worst Pain Per Cycle.(At baseline, prior to each subsequent course (q 28+/- 3 days), and at end of treatment up to 51 months)
Time to Disease Progression as Measured Using Kaplan-Meier Method(From registration to documentation of disease progression up to 26 cycles (28 days/cycle).)
Time to Treatment Failure as Assessed Using the Method of Kaplan-Meier(From the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal up to 51 months.)

研究者

发起方

National Cancer Institute (NCI)

申办方类型

Nih

责任方

Sponsor

研究点 (9)

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