Phase I/II Study of Mesna, Ifosfamide, Teniposide and Weekly Taxol (MITTen) in Relapsed Lymphoma
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: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of ifosfamide, teniposide, and paclitaxel in treating patients who have relapsed non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
- Determine the toxicities associated with the combination of ifosfamide, teniposide, and weekly paclitaxel in patients with relapsed non-Hodgkin's lymphoma.
- Evaluate response rate and time to disease progression in these patients treated with this regimen.
OUTLINE: This is a dose escalation study of teniposide. Patients are stratified according to whether they proceed to stem cell transplant or not.
Patients receive ifosfamide IV over 1-2 hours on days 1-3 every 3 weeks, teniposide IV over 2 hours on day 1 every 3 weeks, and paclitaxel IV over 1 hour weekly. Patients who are not candidates for stem cell transplant continue treatment for 120 days in the absence of disease progression or unacceptable toxicity. Patients proceeding to stem cell transplant continue treatment for 36 days. Peripheral blood stem cells (PBSC) may be harvested at this time if autologous transplant is planned. Transplant patients may then continue with chemotherapy or proceed to autologous or allogeneic PBSC transplant.
Cohorts of 3-5 patients receive escalating doses of teniposide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 5 patients experience dose limiting toxicities.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed intermediate or high grade non-Hodgkin's lymphoma
- •No lymphoblastic or small cleaved lymphoma
- •Progressive disease following doxorubicin based chemotherapy
- •No more than 2 prior treatment regimens
- •Measurable or evaluable disease 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:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Bilirubin no greater than 2 times upper limit of normal
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular:
- •No significant cardiac disease
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No active or uncontrolled second malignancy
- •No other medical problems that would preclude therapy
- •HIV negative
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Prior stem cell transplant allowed
- •Chemotherapy:
- •See Disease Characteristics
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Not specified
- •Not specified
排除标准
- 未提供