Ex Vivo Expanded Megakaryocytes for Supportive Care of Breast Cancer Patients: A Phase I/II Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy.
PURPOSE: Randomized phase I/II trial to study the effectiveness of peripheral stem cell transplantation in treating patients who have breast cancer or hematologic cancer.
详细描述
OBJECTIVES:
- Determine the toxicity of ex vivo expanded megakaryocytes (EVE MK) as a supplement to peripheral blood stem cell (PBSC) transplantation in patients with breast cancer or hematologic malignancies.
- Compare the effect of this treatment regimen on platelet recovery and platelet function in these patients vs historical controls.
- Compare the frequency of malignant cells in the EVE MK vs the uncultured PBSC collection in these patients.
- Determine the optimal time of MK harvest for the production of platelets in vivo.
- Determine the required number of MKs for clinical efficacy in these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 durations of CD34+ culture times (6 days vs 9 days).
After an initial harvest of filgrastim (G-CSF)-mobilized autologous peripheral blood stem cells (PBSC) for transplantation, patients receive one additional dose of G-CSF and undergo one additional apheresis. The CD34+ cells are cultured in the presence of recombinant human thrombopoietin, interleukin-3, and flt3 ligand to expand megakaryocytes. Patients then undergo treatment with high-dose chemotherapy (and, in some cases, total body irradiation) followed by reinfusion of the conventional PBSC harvest and the ex vivo expanded megakaryocytes.
Patients are followed until blood counts recover.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of carcinoma of the breast or hematologic malignancies
- •No metastases to bone marrow
- •Planned high-dose chemotherapy with autologous peripheral blood stem cell transplantation
- •At least 2.0 million CD34+ cells/kg collected
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •Female or male
- •Menopausal status:
- •Not specified
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count greater than 1,500/mm^3
- •Platelet count greater than 100,000/mm^3
- •SGOT or SGPT less than 2.5 times upper limit of normal (ULN)
- •Bilirubin less than 2.5 times ULN (except in Gilbert's syndrome)
- •Alkaline phosphatase less than 2.5 times ULN
- •No active hepatitis B or C
- •Creatinine clearance greater than 50 mL/min
- •Cardiovascular:
- •Normal ejection fraction
- •DLCO at least 50% predicted
- •FEV_1 and/or FVC at least 75% predicted
- •No concurrent serious nonneoplastic disease that would preclude study entry
- •HIV negative
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Disease Characteristics
- •Chemotherapy:
- •See Disease Characteristics
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Not specified
- •Not specified
排除标准
- 未提供