NCT00088166已完成3 期
A Phase III Randomized, Double-Blind, Dexamethasone-Sparing Study Comparing Human Corticotropin-Releasing Factor (hCRF) to Placebo for Control of Symptoms Associated With Peritumoral Brain Edema in Patients With Malignant Brain Tumor Who Require Chronic Administration of High-Dose Dexamethasone
Celtic Pharma Development Services34 个研究点 分布在 2 个国家目标入组 200 人开始时间: 2004年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 34
- 主要终点
- The Proportion of Patients in Each Treatment Group Who Are Responders at Week 2 and Continue to be Responders at Week 5
研究概览
简要总结
The purpose of this study is to compare the safety and efficacy of XERECEPT® to dexamethasone (Decadron) a common treatment for symptoms of brain swelling (edema). This study is specifically aimed at patients who require chronic high doses of dexamethasone to manage symptoms.
详细描述
XERECEPT® is not a potential treatment for cancer, but may reduce the edema associated with tumors and as a result, decrease neurological symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 confirmed diagnosis of a primary malignant brain tumor or, if metastatic, documentation and histology (if available) of primary source of cancer.
- •Patient must have 1 or more qualifying steroid-associated side effect(s) at Baseline.
- •Patient has required administration of dexamethasone to control symptoms of peritumoral edema for at least 30 days.
- •Stable dexamethasone dose of 4-24 mg/day for at least 14 days prior to Baseline.
- •Need for administration of dexamethasone to treat peritumoral brain edema (referenced above) has been documented by MRI or comparable diagnostic technology within 21 days of Baseline.
- •Karnofsky score of > 50 at Screening and Baseline.
- •Capable of self-administration of subcutaneous injections twice daily for 12 weeks, or availability of assistance from caregiver.
- •Ability to provide written informed consent or, if unable to provide, have a legal guardian or representative provide written informed consent.
- •For women of childbearing potential: a negative serum pregnancy test at Screening.
- •Must be 18 years of age or older
排除标准
- •Ongoing or anticipated need for surgery, radiosurgery or radiation therapy or the introduction of new chemotherapeutic regime within the first 5 weeks of study enrollment. Treatment with pre-study chemotherapy may continue.
- •Concurrent enrollment in any other investigational drug or device study, or plan to enroll in such a study during the first 5 weeks of treatment.
- •Systemic steroid use for any indication other than peritumoral brain edema.
- •Use or intended use of dexamethasone as an anti-emetic during Screening or Study
- •Non-compliance with dexamethasone or anticonvulsant therapy.
- •Clinical signs and symptoms of cerebral herniation.
- •Serious concomitant cardiovascular, pulmonary, renal, gastrointestinal or endocrine metabolic disease which could put the patient at unusual risk for study participation.
- •Confounding previous or concurrent neurological disorders that would interfere with adequate clinical evaluation.
- •Clinically significant head injury or chronic seizure disorder, if the condition results in functional impairment or is likely to interfere with evaluations. (Maintenance anticonvulsant therapy is allowed.)
- •Central nervous system infection.
- •Pregnancy, breastfeeding and/or refusal to practice birth control while in study, for women of childbearing potential.
- •Any conditions that are considered contraindications for patients to receive niacin, e.g. liver disease (with LFTs > 3 times the upper limit of the norm),active peptic ulcer, arterial hemorrhage, asthma and known hypersensitivity to niacin.
研究组 & 干预措施
I
Experimental
Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
干预措施: hCRF (Drug)
II
Placebo Comparator
Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
干预措施: placebo hCRF (Drug)
结局指标
主要结局
The Proportion of Patients in Each Treatment Group Who Are Responders at Week 2 and Continue to be Responders at Week 5
时间窗: Prospective
The primary efficacy endpoint was the proportion of patients in each treatment group who were Responders at Week 2 and who continued to be Responders at Week 5. Responders were defined as study patients who demonstrated the following: * 50% or greater reduction in dexamethasone dose relative to Baseline * Overall 10-Item Neurological Examination Score unchanged or lower compared to Baseline * Karnofsky Score unchanged or increased relative to Baseline
次要结局
- Percent of Patients in Each Treatment Group Achieving 50% Reduction in Dexamethasone Usage Relative to Baseline by Week 2 Without Deterioration in Neurological Function as Measured by the 10-Item Neurological Exam and the KPS(Prospective)
- The Proportion of Patients in Each Treatment Group Who Are Responders at Week 2 and Who Continue to be Responders at Weeks 5 and 8(Prospective)
- Change From Baseline in the Karnofsky Performance Score(Prospective)
- Change From Baseline in Myopathy Assessment Results at Week 12 (or Early Study Drug Discontinuation) and Week 16 (or 4-week Follow-up Visit)(Prospective)
- Maximum Percent Reduction in Dexamethasone Usage Relative to Baseline Achieved During the Study(Prospective)
- Change From Baseline in the 10-Item Neurological Examination Score at Weeks 2, 5, 8 12 and 16 (or Early Discontinuation)(Prospective)
- Change From Baseline in the FACT-Br Quality of Life Results(Prospective)
- Number of Patients Who Discontinued Study Drug Prior to the End of Week 5(Prospective)
研究者
研究点 (34)
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