A Pilot Study of Chemotherapy Intensification by Adding Vincristine, Topotecan and Cyclophosphamide to Standard Chemotherapy Agents With an Interval Compression Schedule in Newly Diagnosed Patients With Localized Ewing Sarcoma Family of Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Incidence of Death
研究概览
简要总结
This clinical trial is studying the side effects of combination chemotherapy and to see how well they work in treating patients with newly diagnosed localized Ewing sarcoma family of tumors. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving the drugs in different ways may kill more tumor cells.
详细描述
PRIMARY OBJECTIVES:
I. To assess the feasibility and safety of adding interval-compressed vincristine, topotecan hydrochloride, and cyclophosphamide to a treatment protocol utilizing interval compression of vincristine, doxorubicin hydrochloride, cyclophosphamide, ifosfamide, and etoposide in patients with localized Ewing sarcoma family of tumors.
SECONDARY OBJECTIVES:
I. To estimate the event-free survival in patients treated with this regimen.
OUTLINE: This is a multicenter study.
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
- — 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of extracranial Ewing sarcoma or peripheral primitive neuroectodermal tumor of bone or soft tissue:
- •Newly diagnosed disease
- •Disease confirmed by biopsy only with no attempt at complete or partial resection
- •Unplanned excision allowed provided adequate imaging was obtained prior to surgery and incompletely resected disease is controlled by local therapy
- •No esthesioneuroblastoma
- •Localized disease, including any of the following sites:
- •Chest wall tumors with ipsilateral pleural effusions, ipsilateral positive pleural fluid cytology, or ipsilateral pleural based secondary tumor nodules;
- •No contralateral pleural effusions or pleural nodules
- •Regional lymph nodes that are clinically suspicious or confirmed by biopsy
- •No distant lymph node metastases
- •Extra-dural tumors arising in the bony skull
- •No tumors arising in the intra-dural soft tissue or the intra-dural region of the spine
- •No evidence of metastatic disease, defined as any of the following:
- •Lesions that are discontinuous from the primary tumor
- •Lesions that are not regional lymph nodes
- •Lesions that do not share a body cavity with the primary tumor
- •No evidence by CT scan of metastatic lung disease, defined as any of the following:
- •One pulmonary nodule > 1 cm in diameter or more than one nodule > 0.5 cm diameter
- •Pulmonary nodules that are resected and are not found to be metastatic Ewing sarcoma are allowed
- •Biopsy proven solitary nodules measuring 0.5 to 1.0 cm or multiple nodules measuring 0.3 to 0.5 cm
- •Solitary nodules measuring < 0.5 cm or multiple nodules measuring < 0.3 cm are allowed unless biopsy proven to be metastatic (biopsy is not required)
- •Karnofsky performance status (PS) 0-2 (>= 16 years old) OR Lansky PS 0-2 (< 16 years old)
- •Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR serum creatinine based on age/gender as follows:
- •1 month to < 6 months old (males and females 0.4 mg/dL)
- •6 months to < 1 year old (males and females 0.5 mg/dL)
- •1 to < 2 years old (males and females 0.6 mg/dL)
- •2 to < 6 years old (males and females 0.8 mg/dL)
- •6 to < 10 years old (males and females 1.0 mg/dL)
- •10 to < 13 years old (males and females 1.2 mg/dL)
- •13 to < 16 years old (males 1.5 mg/dL and females 1.4 mg/dL)
- •>= 16 years old (males 1.7 mg/dL and females 1.4 mg/dL)
- •AST or ALT < 2.5 times ULN for age
- •Total bilirubin =< 1.5 times upper limit of normal (ULN) for age
- •Shortening fraction of >= 27% by ECHO or ejection fraction of >= 50% by radionuclide angiogram (MUGA)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No prior chemotherapy or radiotherapy
- •No concurrent pegfilgrastim (Neulasta) or sargramostim (GM-CSF)
- •No other concurrent cancer chemotherapy or immunomodulating agents, including steroids, unless used as an antiemetic
排除标准
- 未提供
研究组 & 干预措施
Treatment (combination chemotherapy)
See Detailed Description
干预措施: radiation therapy (Other)
Treatment (combination chemotherapy)
See Detailed Description
干预措施: therapeutic conventional surgery (Other)
Treatment (combination chemotherapy)
See Detailed Description
干预措施: etoposide (Drug)
Treatment (combination chemotherapy)
See Detailed Description
干预措施: ifosfamide (Drug)
Treatment (combination chemotherapy)
See Detailed Description
干预措施: doxorubicin hydrochloride (Drug)
Treatment (combination chemotherapy)
See Detailed Description
干预措施: cyclophosphamide (Drug)
Treatment (combination chemotherapy)
See Detailed Description
干预措施: vincristine sulfate (Drug)
Treatment (combination chemotherapy)
See Detailed Description
干预措施: topotecan hydrochloride (Drug)
Treatment (combination chemotherapy)
See Detailed Description
干预措施: filgrastim (Biological)
结局指标
主要结局
Incidence of Death
时间窗: Length of protocol therapy (up to 37 weeks) plus 30 days
Incidence of death from complications of therapy while the patient is on protocol therapy or within one month of terminating protocol therapy
Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Enrollment to Week 12
时间窗: Enrollment to week 12
The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks.
Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 13 to Week 22
时间窗: Week 13 to week 22
The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks.
Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 23 to Week 28
时间窗: Week 23 to week 28
The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks.
Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 29 to Week 37
时间窗: Week 29 to week 37
The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks.
次要结局
- Event Free Survival(From enrollment to event or 10 years from enrollment, whichever occurs first)