Multicenter Pilot-study for the Therapy of Medulloblastoma of Adults (NOA-07)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 15
- 主要终点
- feasibility of the adjuvant chemotherapy
研究概览
简要总结
The purpose of this study is to determine whether a combination of a radiochemotherapy (vincristin) and a following maintenance chemotherapy (vincristin, cisplatin and CCNU) in adult patients with medulloblastoma is tolerable.
详细描述
As medulloblastoma in adult patients are very rare (1.1% of all brain tumors), adults are often treated in the scope of expanded access treatments or within pediatric studies; although, it is not known whether medulloblastomas act in the same way in adulthood and in childhood. This is the first study to investigate the significance of a combination of a radiochemotherapy (vincristin) and a following maintenance chemotherapy (vincristin, cisplatin and CCNU) in adult patients with medulloblastoma with the purpose to have a starting point for the development of chemotherapeutical protocols in adults.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 years
- •medulloblastoma (+/- postoperative residual tumor, M0) or medulloblastoma (+/- postoperative residual tumor, M1-M3) respectively
- •primary diagnosis of the tumor
- •no previous chemo- or radiation therapy
- •Karnofsky-Index ≥ 70%
- •WBC ≥ 3000/μl; thrombocytes ≥ 100 000/μl; Hb ≥ 10 g/dl
- •creatinine =< 1,5 ULN; Bilirubin =< 1,5 ULN; GPT, GOT, AP =< 2,5 ULN
- •HIV and hepatitis B/C negative
- •no factors / any medical condition affecting patient's compliance
- •patient needs to fulfil protocol's requirements
- •patient is willing to use highly effective methods of contraception during dosing and for 6 months after the last dose; women of child-bearing potential must have a negative hCG laboratory test at baseline; pregnancy tests must be repeated every 4 weeks
- •patient's written consent
排除标准
- •age < 18 years
- •histologically not confirmed Medulloblastoma
- •by chemo- or radiotherapy treated recidive tumor
- •other cancer (with exception of surgically cured carcinoma in situ of the cervix and non-melanocytic skin tumors)
- •hypersensitivity or contraindication against one of the used drugs
- •current or planned participation to another clinical trial during this study Any other condition which, in the opinion of the Investigator, would make the patient unsuitable for enrolment or could interfere with the patient participating in and completing the study
- •Any medical condition associated with high medical risk or contraindicated to use chemotherapeutic agents as indicated in current product package insert
- •Pregnant or nursing (lactating) women; women or men not willing to use a highly effective methods of contraception
研究组 & 干预措施
Vincristin, CCNU, cis-platin
radiotherapy and concomitant chemotherapy (7 cycles of 7 days):
- 2 mg/m2 vincristin i.v.
- 55,0 Gy Posterior cranial fossa (M0)
- 55,0 Gy Posterior cranial fossa / cerebral metastases + 49,6 Gy spinal metastases (M1-M3)
maintenance chemotherapy (8 cycles of 42 days):
- once at day 1 at each cycle: 70 mg/m2 cis-platin i.v. 75 mg/m2 CCNU oral 2 mg/m2 vincristin i.v.
- once at day 8 and 15 at each cycle: 2 mg/m2 vincristin i.v.
干预措施: maintenance chemotherapy (vincristin, cisplatin and CCNU) (Drug)
Vincristin, CCNU, cis-platin
radiotherapy and concomitant chemotherapy (7 cycles of 7 days):
- 2 mg/m2 vincristin i.v.
- 55,0 Gy Posterior cranial fossa (M0)
- 55,0 Gy Posterior cranial fossa / cerebral metastases + 49,6 Gy spinal metastases (M1-M3)
maintenance chemotherapy (8 cycles of 42 days):
- once at day 1 at each cycle: 70 mg/m2 cis-platin i.v. 75 mg/m2 CCNU oral 2 mg/m2 vincristin i.v.
- once at day 8 and 15 at each cycle: 2 mg/m2 vincristin i.v.
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
feasibility of the adjuvant chemotherapy
时间窗: participants will be followed for the duration of chemo therapy, an expected average of 1 year
The main objective is the feasibility of the adjuvant chemotherapy which has gained the best results when combined with radiotherapy so far. The present protocol is primarily to determine the number of interruptions of the maintenance chemotherapy due to toxicity and the kind of toxicity .
次要结局
- Number of performable cycles in chemo therapy(participants will be followed for the duration of chemo therapy, an expected average of 6 months)
- 3 and 5 years progression-free survival(participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years)
- event-free survival(participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years)
- overall survival(participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years)
- course of cognitive performance/QoL(participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years)
研究者
Peter Hau
Head, Clinical Neurooncology
University of Regensburg