NCT00031083已完成1 期
A Multi-center, Open Label, Two Part, Dose Escalation Study to Determine the Tolerability of Interferon-Beta Gene Transfer (BG00001) in the Treatment of Recurrent or Progressive Grade III and Grade IV Gliomas
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 12
- 试验地点
- 10
研究概览
简要总结
In this study an investigational replication-defective, recombinant adenovirus expressing the interferon-beta gene (BG00001) will be directly injected into tumors, in patients with recurrent Grade III and Grade IV Gliomas, in order to deliver the hIFN-beta gene. The purpose of the study is to evaluate the safety and any harmful effects of injection of BG00001 into brain tumors. Also, this study will help determine whether the virus carrying the beta interferon gene will enter brain tumor cells and cause the cancer cells to die. This study will require one hospital admission for the actual procedure of drug administration. All other visits will be conducted on an out-patient basis
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Must be greater than or equal to 18 years of age.
- •Subjects must have histologically proven GBM, AA, AMO, malignant astrocytoma NOS or gliosarcoma and recurrent or progressive tumor following prior treatment.
- •Tumor must be amenable to radical resection, and resection must be clinically indicated.
- •Must have an ECOG performance status of 0-
- •Must be on anticonvulsant therapy, and must have therapeutic serum levels within 2 weeks prior to Day 1, if therapeutic levels are defined for the anticonvulsant being used.
排除标准
- •Abnormal blood tests exceeding any of the limits defined below:
- •Alanine transaminase (ALT) > four times (4X) the upper limit of normal (ULN).
- •Aspartate transaminase (AST) > 4X the ULN.
- •Total bilirubin >1.5 mg/dL.
- •Absolute neutrophil count <1,500 cells/mm
- •Platelet count <100,000 cells/mm
- •Serum creatinine >2X ULN.
- •Prothrombin time (PT) >2 seconds above the ULN.
- •Serum sodium (Na) <125 mEq/L or >150 mEq/L.
- •Serum potassium (K) <3.5 mEq/L or > 5.5 mEq/L.
- •Brainstem, or optic chiasm involvement of tumor.
- •Uncontrolled seizure disorder.
- •History of a new diagnosis or treatment of an invasive malignancy other than Grade III or Grade IV Glioma within 5 years of enrollment. Curatively treated subjects with a history of basal cell or squamous cell carcinoma of the skin, superficial transitional cell carcinoma of the bladder, and non-invasive carcinoma of the uterine cervix are not excluded.
- •Treatment History:
- •Treatment with radiation therapy, including interstitial radiation or radiosurgery, must be completed at least 8 weeks prior to Day
- •Treatment with nitrosoureas must be completed at least 6 weeks prior to Day
- •Treatment with other chemotherapeutic agents must be completed at least 4 weeks prior to Day
- •Treatment with any investigational drug or approved therapy for investigational use must be completed at least 4 weeks prior to Day
- •History of intolerance to corticosteroids that would preclude use during this study, or history of any medical condition that precludes the use of corticosteroids.
- •Any prior treatment with a gene delivery vector, or an adenovirus therapeutic.
- •Women of child bearing potential must have a negative serum pregnancy test.
- •Women who are not postmenopausal, surgically sterile, or willing to practice effective contraception during the study. Men who are not surgically sterile or willing to practice effective contraception during the study.
- •Nursing mothers, pregnant women and women planning to become pregnant while on study.
- •Previous treatment with BG00001.
研究者
研究点 (10)
Loading locations...
相似试验
进行中（未招募）
2 期
A Study Comparing Two Doses of AGTC-501 in Male Subjects With X-linked Retinitis Pigmentosa Caused by RPGR Mutations (SKYLINE)X-Linked Retinitis PigmentosaNCT06333249Beacon Therapeutics14
进行中（未招募）
1 期
Safety and Efficacy of rAAV2tYF-GRK1-RPGR in Subjects With X-linked Retinitis Pigmentosa Caused by RPGR MutationsX-Linked Retinitis PigmentosaNCT03316560Beacon Therapeutics29
已完成
1 期
Safety and Efficacy of rAAV-hRS1 in Patients With X-linked Retinoschisis (XLRS)X-linked RetinoschisisNCT02416622Applied Genetic Technologies Corp27
进行中（未招募）
1 期
Study of Recombinant Adenovirus AdVince in Patients With Neuroendocrine Tumors; Safety and EfficacyNeuroendocrine TumorsNCT02749331Uppsala University35
已完成
1 期
Phase I Randomized Study of Adeno-Associated Virus-CFTR Vector in Patients With Cystic FibrosisCystic FibrosisNCT00004533National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)19