Pilot Study of the Safety and Feasibility of Autologous Peripheral Blood Stem Cell Transplantation for Patients With Relapsed AIDS-Related Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 4
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have recurrent or refractory AIDS-related lymphoma.
详细描述
OBJECTIVES:
- Determine the safety and tolerability of intensive chemotherapy and autologous peripheral blood stem cell transplantation in patients with recurrent or refractory AIDS-related lymphoma.
- Determine the response and response duration in these patients treated with this regimen.
- Determine the effect of this treatment regimen on HIV RNA and CD4 cells in these patients.
OUTLINE: Patients receive mobilization chemotherapy consisting of cyclophosphamide IV over 2 hours followed 2 days later by daily filgrastim (G-CSF) subcutaneously (SC) until blood counts recover. Patients then undergo leukopheresis to collect CD34+ cells.
Patients receive conditioning chemotherapy consisting of oral busulfan every 6 hours on days -7, -6, -5, and -4 for a total of 14 doses and cyclophosphamide IV over 1 hour on days -3 and -2. Patients undergo autologous stem cell infusion on day 0. G-CSF is administered IV or SC daily beginning on day 1 and continuing until blood counts recover.
Patients are followed monthly for 1 year and then every 6 months for 2 years.
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
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Intermediate- or high-grade non-Hodgkin's lymphoma or Hodgkin's disease
- •Failed to achieve complete remission with initial therapy OR
- •Relapsed after initial therapy
- •May be in complete remission after salvage therapy
- •Sensitive to most recent chemotherapy
- •Improvement of at least 25% in bidimensional tumor measurements OR
- •Improvement in evaluable disease sustained over 4 weeks
- •Measurable or evaluable disease
- •HIV-1 positive
- •CD4 greater than 50 cells/mm^3 (unless not receiving optimal antiretroviral therapy)
- •HIV RNA less than 110,000 copies/mL (unless not receiving optimal antiretroviral therapy)
- •No active leptomeningeal or parenchymal CNS involvement NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
- •PATIENT CHARACTERISTICS:
- •Physiologic 18 and over
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count greater than 1,000/mm^3
- •AST no greater than 3 times upper limit of normal
- •Bilirubin no greater than 2.0 mg/dL (unless receiving indinavir)
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular:
- •No history of cardiac disease
- •LVEF at least 45%
- •No history of symptomatic pulmonary disease
- •DLCO at least 60%
- •No active opportunistic infections
- •No cytomegalovirus retinitis or pneumonitis requiring maintenance therapy
- •No sensitivity to E. coli-derived products
- •Not pregnant
- •Negative pregnancy test
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •See Disease Characteristics
- •At least 1 week since prior chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Not specified
- •Not specified
- •Chronic suppressive therapy for infection allowed
排除标准
- 未提供