CLINICAL TRIAL: HCRF FOR PATIENTS WITH MALIGNANT BRAIN TUMOR WHO REQUIRE HIGH-DO

临床试验：HCRF 适用于需要高剂量治疗的恶性脑肿瘤患者

• 批准号: 7717889
• 负责人: Lawrence D Recht
• 金额: $ 0.08万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7717889
• 关键词: Blinded; Brain Edema; Chronic; Clinical; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Corticotropin-Releasing Hormone; Daily; Dexamethasone; Dose; Double-Blind Method; Funding; Grant; Human; Institution; Karnofsky Performance Status; Label; Malignant neoplasm of brain; Measures; Neurologic; Patients; Performance; Pharmaceutical Preparations; Phase; Physicians; Placebo Control; Protocols documentation; Quality of life; Randomized; Research; Research Personnel; Resources; Safety; Score; Signal Transduction; Source; Steroids; Symptoms; Title; Toxic effect; United States National Institutes of Health; Visit; follow-up

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is an extended-use study for GCRC protocol #893, Protocol ID: 1654, Title: NTI 0303: A Phase III Randomized, Double-Blind, Dexamethasone-Sparing Study Comparing Human Comparing Corticotropin-Releasing Factor (hCRF) To Placebo For Control Of Symptoms Associated With Periturmoral Brain Edema In Patients With Malignant Brain Tumor Who Require Chronic Administration of High-Dose Dexamethasone. This open-label, extended-use study is open to all patients who participate in either of the blinded studies, NTI 0302 or NTI 0303, including patients who may have discontinued blinded study medication early but completed the protocol-stipulated follow-up periods. The objective of this study is to examine the long-term safety and tolerability of human corticotropin-releasing factor (hCRF) in patients requiring dexamethasone to treat peritumoral brain edema. The study will evaluate overall safety of hCRF and steroid toxicities. Throughout the course of the study, treating physicians will be asked to attempt and maintain a maximum possible reduction in baseline dexamethasone. At monthly visits, the current daily dexamethasone dosing will be recorded, as well as highest and lowest daily dexamethasone dose since the last visit. Neurological and clinical status will be measured by the Signal Neurological Symptom assessment, Karnofsky Performance Score, 10-Item Neurological Exam Score and FACT-Br Quality of Life module results.

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