A Phase II Trial of Intensive Chemotherapy and Autotransplantation for Patients With Newly Diagnosed Anaplastic Oligodendroglioma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Progession Free Survival
研究概览
简要总结
The purpose of this study is to see how effective treatment of high doses of chemotherapy is for your tumor. We will also be looking at the side effects and risks of this treatment.
You will receive very high doses of chemotherapy. High doses of chemotherapy can destroy tumor cells, but it can also destroy normal bone marrow cells. These cells produce white blood cells (which fight infection), red blood cells (which carry oxygen) and platelets (which allow your blood to clot). With too few of these cells there is a serious risk of infection and bleeding.
Therefore, before treatment begins, we will collect some of your own blood cells, called peripheral blood progenitor cells (PBPCs). These cells help create new blood cells. The PBPCs are frozen and saved while you are being treated. Then at the end of treatment, your PBPCs are thawed and given back to you. These healthy PBPCs will replace the blood cells that the high dose chemotherapy destroys and allow your bone marrow to recover and produce blood cells. In a prior study we treated 69 patients in a similar way. More than half were able to avoid or delay brain radiation. This new study will use a different high dose chemotherapy regimen.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologic evidence of an anaplastic oligodendroglioma. For this study, World Health Organization classification criteria will be used. Central pathology review must take place prior to high-dose therapy but need not occur prior to study entry and induction therapy.
- •Pathologic evidence of an anaplastic mixed glioma (i.e. oligoastrocytoma). Again, histopathologic diagnosis will be made using World Health Organization classification criteria. To qualify as a mixed tumor there must be a minimum of 25% oligodendroglial element. Central pathology review must take place prior to high-dose therapy but need not occur in advance of enrollment or induction therapy.
- •The diagnostic surgical procedure may have been a complete resection, partial resection, or biopsy.
- •Karnofsky performance status > or equal to
- •Granulocyte count > or equal to 1.5 X 109/L.
- •Platelet count > or equal to 100 X 109/L
- •SGOT < than or equal to 2X upper limit of normal.
- •Serum creatinine < than or equal to 1.5X upper limit of normal
- •Bilirubin < than or equal to 1.5X upper limit of normal
- •All patients must sign written informed consent.
排除标准
- •Systemic or leptomeningeal metastases (excluding contiguous leptomeninges)
- •Prior cranial radiotherapy or systemic chemotherapy
- •Other concurrent malignancy (with the exception of cervical carcinoma in situ or basal cell carcinoma of the skin) or serious illness if this would interfere with the prescribed treatment.
- •Pregnant or lactating women
- •Refusal to use effective contraception
研究组 & 干预措施
1
temozolomide followed by high dose busulfan and thiotepa
干预措施: temozolomide followed by high dose busulfan and thiotepa (Drug)
结局指标
主要结局
Progession Free Survival
时间窗: 2 years
To determine the duration of disease control of newly diagnosed pure and mixed anaplastic oligodendrogliomas treated with dose-intensive chemotherapy requiring hematopoietic stem cell support.
次要结局
- Number of Participants Evaluated for Toxicities(up to 2 years)