A Phase II Study Of Mobilization Chemotherapy With GMCSF And GCSF Followed By High Dose Therapy Combined With IL2 Activated Autologous Peripheral Blood Stem Cells Followed By Sequential IL2 Therapy As Treatment For Solid Tumors And Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Biological therapies such as interleukin-2 use different ways to stimulate the immune system and stop cancer cells from growing.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, peripheral stem cell transplantation, and interleukin-2 in treating patients who have solid tumors or lymphoma.
详细描述
OBJECTIVES:
- Determine the toxicity of sargramostim (GM-CSF) and filgrastim (G-CSF)-mobilized interleukin-2(IL-2)-incubated autologous peripheral blood stem cells and sequential IL-2 in patients with solid tumors or lymphoma.
- Determine the ability of cyclophosphamide and paclitaxel followed by GM-CSF and G-CSF to mobilize adequate numbers of CD34+ cells and immune cells in these patients.
- Determine the time to neutrophil and platelet engraftment in patients treated with this regimen.
- Determine the overall and disease-free survival of patients treated with this regimen.
OUTLINE: Patients receive cyclophosphamide IV over 1-2 hours on day 1 and paclitaxel IV over 4 hours on day 2. Patients also receive sargramostim (GM-CSF) subcutaneously (SC) alone on days 3-9 and GM-CSF and filgrastim (G-CSF) SC beginning on day 10 and continuing until leukapheresis is completed.
Patients receive high-dose chemotherapy comprising oral busulfan every 6 hours on days -8 to -6, melphalan IV on days -5 and -4, and thiotepa IV on days -3 and -2. Autologous peripheral blood stem cells (PBSC) are treated ex vivo with interleukin-2 (IL-2) on day -1. Patients undergo IL-2-treated autologous PBSC transplantation on day 0.
Beginning 4 hours after PBSC transplantation, patients receive IL-2 IV continuously for 5 days. IL-2 therapy repeats every 7 days for 4 courses.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 56 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of solid tumor, Hodgkin's lymphoma, or B-cell non-Hodgkin's lymphoma
- •Eligible for autologous stem cell transplantation
- •No pleural effusion, pericardial effusion, or ascites
- •No T-cell lymphoma
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Karnofsky 80-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Bilirubin no greater than 1.5 mg/dL (unless due to Gilbert's disease)
- •SGOT or SGPT no greater than 2 times upper limit of normal
- •Hepatitis B and C negative
- •Creatinine no greater than 2.0 mg/dL OR
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular:
- •LVEF at least 50%
- •No congestive heart disease
- •No history of myocardial infarction within the past year
- •No coronary artery disease
- •No history of arrhythmia
- •Diffusion capacity (corrected) at least 60%
- •FEV_1 at least 65% of predicted
- •HIV negative
- •No history of seizures
- •No mental disorders requiring medication (e.g., haloperidol)
- •No active connective tissue disease
- •No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or any carcinoma in situ
- •No allergy to gentamicin
- •No hypersensitivity to E. coli-derived preparations
- •No history of severe allergy to sargramostim (GM-CSF) or filgrastim (G-CSF)
- •No systemic infection
- •Not pregnant
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Disease Characteristics
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •No concurrent corticosteroid therapy
- •Radiotherapy:
- •Not specified
- •Not specified
- •No contrast dye for 3 weeks after completion of interleukin-2 therapy
排除标准
- 未提供