NCT00165360已完成2 期
A Phase II Study of Prolonged Daily Temozolomide for Low-Grade Glioma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 4
- 主要终点
- To determine the effects temozolomide has on low-grade gliomas
研究概览
简要总结
The purpose of this trial is to determine the effects (good and bad) temozolomide has on patients with low-grade glioma. It will also determine whether temozolomide is effective in preventing or delaying future tumor growth.
详细描述
- Treatment with temozolomide is based upon an 11-week cycle (7 weeks on the drug and 4 weeks off). Patients will receive temozolomide once daily for 49 days, then have 28 days without taking temozolomide.
- Every two to four weeks a physical and neurological examination and blood work will be performed. A magnetic resonance imaging (MRI) scan of the patient's brain will be done approximately every three months (before each cycle of treatment).
- Treatment may continue for a maximum of a year and a half based on 6 eleven-week cycles. The actual duration of therapy will depend upon the response to treatment and the development of side effects or toxicity.
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
- •Histological confirmation of a low-grade glioma (astrocytoma, oligodendroglioma, or mixed oligoastrocytoma)
- •Measurable disease on MRI
- •Patients that have undergone recent resection for newly diagnosed or recurrent or progressive tumor are eligible if they have recovered from the effects of surgery.
- •Patients with recurrent disease my have had one prior chemotherapy regimen
- •Older than 18 years of age.
- •Karnofsky performance status (KPS) performance score of > 70%
- •Adequate hematologic, renal and liver functions,
- •Life expectancy of greater than 12 weeks.
- •Negative pregnancy test.
排除标准
- •Prior treatment with temozolomide
- •Patients who are not neurologically stable
- •Acute infection treated with intravenous antibiotics
- •Non-malignant systemic disease
- •Frequent vomiting, inability to swallow or a medical condition that could interfere with oral medication.
- •Previous or concurrent malignancies at other sites, with the exception of surgically cured carcinoma in-situ of the cervix, and basal or squamous cell carcinoma of the skin.
- •HIV positive or AIDS-related illness
- •Pregnant or nursing women
- •Patients with allergy to decarbazine.
结局指标
主要结局
To determine the effects temozolomide has on low-grade gliomas
时间窗: 3 years
次要结局
- To determine whether temozolomide is effective in preventing or delaying future tumor growth(3 years)
- to determine the safety of temozolomide(3 years)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
2 期
Efficacy of Protracted Temozolomide in Patients With Progressive High Grade GliomaOligodendrogliomaBrain Tumor, RecurrentGlioblastomaAstrocytomaNCT00575887Marmara University25
已完成
2 期
Study of Temozolomide in Previously Untreated Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Participants With Low O6-Methylguanine Methyltransferase (MGMT) Expression (P05052)Leukemia, Acute MyeloidMyelodysplastic SyndromeNCT00687323Merck Sharp & Dohme LLC47
已完成
2 期
Continuous Temozolomide in Patients With Advanced or Metastatic Soft Tissue Sarcoma or Metastatic Breast CancerSoft Tissue SarcomaBreast CancerNCT00194766University of Washington35
已完成
2 期
Temozolomide 12 Cycles Versus 6 Cycles of Standard First-line Treatment in Patients With Glioblastoma.GlioblastomaNCT02209948Grupo Español de Investigación en Neurooncología166
终止
2 期
Study of Maintenance Temozolomide Versus Observation in Stable or Responding Stage III/IV Non-Small Cell Lung Cancer Patients (Study P05146)Carcinoma, Non-Small-Cell LungAdenocarcinomaCarcinoma, Large CellCarcinoma, Squamous CellNCT00632203Merck Sharp & Dohme LLC53