Adaptive Randomization of Fludarabine-Melphalan Versus Fludarabine-Cyclophosphamide Conditioning Regimen in Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Using HLA-Matched Related Donor for Metastatic Renal Cell Carcinoma

M.D. Anderson Cancer Center1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2004年1月最近更新: 2013年3月4日

适应症

干预措施

试验速览

阶段: 2 期
状态: 终止
发起方: M.D. Anderson Cancer Center
入组人数: 40
试验地点: 1
主要终点: Survival Rate

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Primary Objectives:

To compare the overall survival of metastatic renal cell carcinoma (RCC) patients undergoing HLA-matched related donor nonmyeloablative allogeneic hematopoietic stem cell transplantation (NST) using fludarabine-melphalan (FM) versus fludarabine-cyclophosphamide (FC) conditioning regimen.
To assess both cytotoxic T lymphocyte reactivity and antibodies activity against potential tumor antigenic peptides involved in graft-versus-RCC effect.

Secondary Objectives:

To study the patient characteristics of metastatic RCC patients who undergo NST and those who do not undergo NST.
To compare the incidence of Day-100 treatment-related mortality in FM group and FC group.

详细描述

Registration:

When you are willing to undergo stem cell transplantation for kidney cancer, have possible related donors, and the study doctor decides you are eligible to participate, you will be enrolled in this study.

Before treatment begins, you will have a complete physical exam, including blood (about 1-2 tablespoons) and urine tests. An electrocardiogram (ECG--a test to measure the electrical function of the heart) and a heart scan will be done. A test of lung function will be done. This will involve blowing into a machine that records your lung capacity. Tissue typing will also be done by blood test on you and your possible donors to find out if you have a donor or not. Women who are able to have children must have a negative blood test in order to participate.

If you have a suitable related donor, have financial approval for the transplant procedure, and are still eligible in this study, you will go for the stem cell transplantation. A separate informed consent about the transplant procedure will be provided to you. You will need to sign and agree with the second informed consent before the start of treatment. This informed consent is only for you to be enrolled and registered in the study.

If you have no suitable related donor, no financial approval for the transplant procedure, and/or you refuse to undergo transplant for non-medical reasons, you will not have a stem cell transplant but will still remain in our study. You can receive any form of non-transplant treatment from your physician. Study researchers will only follow your progress, so that in the future, they can compare your progress with those who had the stem cell transplant.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: — 至 65 Years（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•For registration: Willing to undergo allogeneic transplantation.
•For registration: Age equal to or less than 65 years old.
•For registration: Metastatic RCC with predominant conventional cell type.
•For registration: Prior nephrectomy.
•For registration: Stage IV RCC. If patient has prior single brain metastasis treated with complete surgical resection or stereotactic radiation therapy, no recurrence or brain edema from the end of treatment for at least 6 months has to be shown by radiological imaging.
•For registration: Zubrod performance status < one.
•For registration: Potential related donor for allogeneic stem cell transplantation.
•For registration: At least one prior treatment for metastatic RCC. Radiation therapy or surgery is not counted as a treatment.
•For registration: Signed an informed consent.
•For transplantation: Zubrod performance status < one.
•For transplantation: An HLA-matched (defined as 6/6 matches) related donor.
•For transplantation: Failed at least one prior treatment for metastatic RCC. Radiation therapy or surgery is not counted as a treatment.
•For transplantation: Adequate major organ functions (see section 4.17-4.20).
•For transplantation: Signed an informed consent for allogeneic stem cell transplantation.

排除标准

•For registration: Prior history of allogeneic stem cell transplantation.
•For registration: Histologic feature with predominant non-conventional cell type.
•For registration: Multiple brain metastasis.
•For registration: Life expectancy is severely limited by concomitant illness.
•For transplantation: Multiple brain metastasis.
•For transplantation: Life expectancy is severely limited by concomitant illness.
•For transplantation: Clinically significant active infections.
•For transplantation: HIV infection.
•For transplantation: Chronic active hepatitis
•For transplantation: Pregnant or lactating women.
•For transplantation: Has all three risk factors: high serum lactate dehydrogenase, low hemoglobin, high corrected serum calcium.