Risk-Adapted High Dose Chemoradiotherapy and Autologous Stem Cell Transplantation for Patients With Relapsed and Primary Refractory Hodgkin's Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Overall Objective Response
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving combination chemotherapy and radiation therapy with an autologous stem cell transplant, using peripheral stem cells or bone marrow from the patient, may allow more chemotherapy to be given so that more cancer cells are killed. Giving combination chemotherapy together with radiation therapy before an autologous stem cell transplant may be an effective treatment for Hodgkin's lymphoma.
PURPOSE: This phase II trial is studying how well combination chemotherapy and radiation therapy work in treating patients who are undergoing an autologous stem cell transplant for relapsed or refractory Hodgkin's lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine whether event-free survival of patients with low to high-intermediate risk, relapsed or refractory Hodgkin's lymphoma can be improved when treated with cytoreductive combination chemotherapy followed by radiotherapy, high-dose combination chemotherapy, and autologous stem cell transplantation.
Secondary
- Determine the toxic effects of this regimen in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic diagnosis of Classical Hodgkin's Lymphoma. Lymphocyte predominant histology will be excluded.
- •Primary refractory or relapsed disease proven by biopsy or fine needle aspiration (cytology) of an involved site
- •Failure of doxorubicin or nitrogen mustard containing front-line therapy
- •18F-fluorodeoxyglucose-PET scan demonstrating PET avid disease
- •Cardiac ejection fraction of greater than 45%, measured since last chemotherapy.
- •Adjusted diffusing capacity of greater than 50% on pulmonary function testing, measured since last chemotherapy
- •Serum creatinine < than or = to 1.5 mg/dl; if creatinine >1.5 mg/dl then the measured 12- or 24-hour creatinine clearance must be >60 ml/minute.
- •ANC>1000/μl and Platelets>50,000/μl
- •Total bilirubin < than or = to 2.0 mg/dl in the absence of a history of Gilbert's disease.
- •Females of childbearing age must be on an acceptable form of birth control.
- •Age between 18 and 72
- •HIV I and II negative.
- •Patients or their guardians must be capable of providing informed consent.
排除标准
- •Histology for Lymphocyte predominant subtype Hodgkin's Lymphoma
- •Prior treatment with carboplatin, cisplatin, ifosfamide, gemcitabine, or vinorelbine
- •Hepatitis B surface antigen positive.
- •Known pregnancy or breast-feeding.
- •Medical illness unrelated to Hodgkin's Lymphoma, which, in the opinion of the attending physician and/or principal investigator, will preclude administering chemotherapy safely.
- •History of any malignancy for which the disease-free interval is <5 years, excluding curatively treated cutaneous basal cell or squamous cell carcinoma and carcinoma in-situ of the cervix
研究组 & 干预措施
Cytoreductive chemotherapy group 1
Patients receive ICE comprising ifosfamide IV and carboplatin IV once on day 2 and etoposide IV over 1 hour once daily on days 1-3. Patients then receive ifosfamide IV twice on day 15, carboplatin IV once on day 17 and etoposide IV over 1 hour twice daily on days 15-17.
干预措施: carboplatin (Drug)
Cytoreductive chemotherapy group 1
Patients receive ICE comprising ifosfamide IV and carboplatin IV once on day 2 and etoposide IV over 1 hour once daily on days 1-3. Patients then receive ifosfamide IV twice on day 15, carboplatin IV once on day 17 and etoposide IV over 1 hour twice daily on days 15-17.
干预措施: etoposide (Drug)
Cytoreductive chemotherapy group 1
Patients receive ICE comprising ifosfamide IV and carboplatin IV once on day 2 and etoposide IV over 1 hour once daily on days 1-3. Patients then receive ifosfamide IV twice on day 15, carboplatin IV once on day 17 and etoposide IV over 1 hour twice daily on days 15-17.
干预措施: ifosfamide (Drug)
Cytoreductive chemotherapy group 2
Patients receive ifosfamide IV twice on days 1 and 17, carboplatin IV once on days 3 and 19, and etoposide IV over 1 hour twice daily on days 1-3 and 17-19.
干预措施: carboplatin (Drug)
Cytoreductive chemotherapy group 2
Patients receive ifosfamide IV twice on days 1 and 17, carboplatin IV once on days 3 and 19, and etoposide IV over 1 hour twice daily on days 1-3 and 17-19.
干预措施: etoposide (Drug)
Cytoreductive chemotherapy group 2
Patients receive ifosfamide IV twice on days 1 and 17, carboplatin IV once on days 3 and 19, and etoposide IV over 1 hour twice daily on days 1-3 and 17-19.
干预措施: ifosfamide (Drug)
结局指标
主要结局
Overall Objective Response
时间窗: 3 years
Overall objective response to therapy Complete remission/unconfirmed (CRu) This includes patients who meet criteria for CR with the following exceptions: 1. A residual lymph node mass \> 1.5 cm in the short axis with normalization of 18Ffluorodeoxyglucose- PET scan Partial remission/minimal response (PR and MR) 1. Any decrease in lymph nodes and nodal-based masses 2. Any decrease in PET avidity (however, residual FDG uptake is present) 3. Involving organs involved prior to therapy must have diminished in size. 4. No new sites of disease Stable disease Response is less than that which constitutes a PR and disease does not meet criteria for progressive disease Progressive disease 1. Increase in lymph nodes or nodal-based masses, or other measurable disease from pretreatment observations. 2. Appearance of any new lesion at the end of therapy
次要结局
未报告次要终点