A Phase I/ II Study of Hypofractionated Radiotherapy With Concurrent Temozolomide Followed by Adjuvant Temozolomide in Patients Over 70 Years Old With Newly Diagnosed Glioblastoma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Number of patients who stop treatment due to Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or above toxicities..
研究概览
简要总结
In this study we propose to determine outcomes of patients age 70 or older treated with radiation over 2 weeks given with temozolomide 75 mg/m2 daily during radiotherapy and as a post radiation treatment of 150 mg/m2 - 200 mg /m2 for 6 cycles or until the disease progresses.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have histologically confirmed glioblastoma/gliosarcoma.
- •Tumor o6-methylguanine-DNA-methyltransferase promoter methylation status must be determined
- •Participants must not have had any prior therapy for glioblastoma multiforme including radiation or chemotherapy.
- •Participants must be > 70 years of age.
- •Participants must have life expectancy greater than 6 months.
- •Karnofsky performance status > 60 (ECOG < 2).
- •Patients must have normal organ and marrow function
- •Leukocytes > 3,000/microliter
- •Absolute neutrophil count > 1,500/microliter
- •Platelets > 100,000/microliter
- •Total bilirubin within normal institutional limits 12
- •aspartate aminotransferase test(SGOT)/alanine aminotransferase test(SGPT) < 2.5 X institutional upper limit of normal
- •Creatinine within normal institutional limits or creatinine clearance > 60 mL/min/1.73 m2 for subjects with creatinine levels about institutional normal
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Participants may not be receiving any other study agents.
- •Participants may not have had chemotherapy wafer placement at surgery.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide.
- •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
- •HIV-positive individuals on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with temozolomide. In addition, these individuals are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.
研究组 & 干预措施
Hypofractionated radiotherapy and temozolomide
All subjects will receive treatment as is a single arm study. Two weeks of combined hypofractionated radiotherapy with concurrent temozolomide followed by up to 6 cycles of adjuvant temozolomide treatment.
干预措施: Hypofractionated radiotherapy (Radiation)
Hypofractionated radiotherapy and temozolomide
All subjects will receive treatment as is a single arm study. Two weeks of combined hypofractionated radiotherapy with concurrent temozolomide followed by up to 6 cycles of adjuvant temozolomide treatment.
干预措施: Temozolomide (Drug)
结局指标
主要结局
Number of patients who stop treatment due to Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or above toxicities..
时间窗: baseline, 14-28 days post-surgery, 4 weeks post chemo-radiation therapy, 1, 2, 3, 4, 5, and 6 months post Radiation Therapy
If \< 4 out of 10 patients in the initial analysis stop treatment due to toxicity it can proceed to phase II.
Overall survival
时间窗: From date of intervention until the date of first documented disease progression or death, the date of study discontinuation (e.g. toxicity, PI decision) or death from any cause, whichever is first, assessed up to 100 months.
Survival status will be collected after completion of chemo-radiation at minimum every 3 months for up to 12 months, then every 6 months until date of death.
次要结局
- Estimate progression-free survival (PFS)(From date of intervention until the date of first documented disease progression or death, the date of study discontinuation (e.g. toxicity, PI decision) or death from any cause, whichever is first, assessed up to 100 months.)
- Tolerability (feasibility) of hypo-fractionated radiaton therapy and Temozolomide(From date of intervention until the date of first documented disease progression or death, the date of study discontinuation (e.g. toxicity, PI decision) or death from any cause, whichever is first, assessed up to 100 months.)
研究者
Adrianna H Masters
Assistant Professor
University of Louisville