Advertisement

Topics

Conditioning Regimen in Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation

2014-08-27 03:40:25 | BioPortfolio

Summary

Primary Objectives:

1. 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.

2. To assess both cytotoxic T lymphocyte reactivity and antibodies activity against potential tumor antigenic peptides involved in graft-versus-RCC effect.

Secondary Objectives:

1. To study the patient characteristics of metastatic RCC patients who undergo NST and those who do not undergo NST.

2. To compare the incidence of Day-100 treatment-related mortality in FM group and FC group.

Description

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.

This is an investigational study. About 480 patients will take part in this study. All patients will be enrolled at M. D. Anderson Cancer Center.

Treatment:

The two different chemotherapy regimens used in this study are fludarabine and melphalan, or fludarabine and cyclophosphamide. They act by suppressing our immune system and make space in our bone marrow so as to prepare for the new bone marrow to grow.

Before treatment starts, 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 activity 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. Tests will be performed to look at the status of your cancer, including chest x-ray, bone scan, CT scans, and MRI scan if needed. You will have a dental exam. Women who are able to bear children must have a negative blood pregnancy test in order to participate.

In this study, you will receive high-dose chemotherapy to prepare for the blood stem cell transplant. Two different types of chemotherapy will be used. You will be assigned to receive one of the chemotherapy treatments. As the study moves forward, the group treatment that is shown to be more effective will receive more new participants than the other one. The first chemotherapy treatment is a combination of fludarabine and melphalan. The second chemotherapy treatment is a combination of fludarabine and cyclophosphamide. The drug fludarabine will be given through a needle in your vein on Days 1-5. Depending on which treatment group you are assigned to, the drugs melphalan or cyclophosphamide will be given through a needle in your vein on Days 4 and 5, along with your scheduled dose of fludarabine. Day 6 will be a rest day; no drugs will be given. The stem cell transplant will be performed on Day 7. Bone marrow from the donor may be used instead of blood stem cells, if the collection of blood stem cells is not enough. A catheter (a tube) will be placed in a large vein in your chest to decrease the number of times you are stuck with a needle.

Blood stem cells will be collected from your family member, who has been using G-CSF to prepare for the transplant. They will need to have enough stem cells before transplantation.

The drugs tacrolimus and methotrexate will be given to ease side effects after the transplant. Tacrolimus is given by vein or by mouth for 2 to 3 months after the transplant. During the last month it is given, the dose will be decreased gradually. Methotrexate is given by vein on Days 1, 3, and 6 after the transplant. An extra dose of methotrexate will be given on Day 11, if your donor is your parent or child. Blood transfusions may be needed also.

Sometimes, the transplanted cells attack the normal cells in your body instead of the cancer cells. This is called graft-versus-host disease (GVHD). The drug methylprednisolone will be given by vein or by mouth to fight GVHD if it happens.

You must stay in the hospital for about 3 to 4 weeks. You must stay in the Houston area for about 100 days after the transplant. Blood tests (about 1-2 tablespoons) will be done every day while you are in the hospital. Chest x-rays, CT scans, and bone scans will be done once a month during the 100 days, and then every 3 months for the first year after that, so that researchers can follow your disease response.

If there are no signs of disease after 100 days, treatment will stop. You must return to the clinic for checkups every 3 months for the first year, then 3 times a year for the next 4 years, and once a year after that. If the disease is still present after 2 months, but you do not have GVHD, the anti-rejection medicine tacrolimus will be stopped within 2 weeks. Then if the disease is still present after another 6 weeks, but you do not have GVHD, you may receive an injection of donor lymphocytes by vein. This treatment may be repeated up to 3 times, with 6 weeks between each time.

If no disease is found or if GVHD occurs, treatment will stop.

This is an investigational study. About 80 participants enrolled in this study will take part in the stem cell transplant. All will be enrolled at M. D. Anderson Cancer Center.

Study Design

Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Renal Cell Cancer

Intervention

Fludarabine, Melphalan, Cyclophosphamide, Stem Cell Transplant

Location

U.T. M.D. Anderson Cancer Center
Houston
Texas
United States
77030

Status

Terminated

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:40:25-0400

Clinical Trials [9985 Associated Clinical Trials listed on BioPortfolio]

Mismatched Transplantation Using High-dose Post-transplant Cyclophosphamide

The goal of this clinical research study is to learn about the safety of giving a stem cell transplant from a tissue-mismatched donor, followed by cyclophosphamide, to patients with certai...

Busulfan, Cyclophosphamide, and Melphalan or Busulfan and Fludarabine Phosphate Before Donor Hematopoietic Cell Transplant in Treating Younger Patients With Juvenile Myelomonocytic Leukemia

This randomized phase II trial studies how well giving busulfan, cyclophosphamide, and melphalan or busulfan and fludarabine phosphate before donor hematopoietic cell transplant works in t...

Fludarabine and Alemtuzumab or Cyclophosphamide Followed by Peripheral Blood Stem Cell Transplant or Alemtuzumab in Treating Patients With Advanced or Progressive Chronic Lymphocytic Leukemia

RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them ...

Fludarabine and Cyclophosphamide Followed by Peripheral Stem Cell Transplant in Treating Patients With Leukemia or Lymphoma

RATIONALE: Giving chemotherapy drugs, such as fludarabine and cyclophosphamide, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps st...

Melphalan, Fludarabine, and Alemtuzumab Followed by Peripheral Stem Cell Transplant in Treating Patients With Hematologic Cancer

RATIONALE: Giving low doses of chemotherapy, such as melphalan and fludarabine, and a monoclonal antibody, such as alemtuzumab, before a donor bone marrow or peripheral blood stem cell tra...

PubMed Articles [28915 Associated PubMed Articles listed on BioPortfolio]

A Retrospective Comparison of TECAM and BEAM Conditioning Regimens Before Autologous Hematopoietic Stem Cell Transplant in Lymphoma Patients: Efficacy and Toxicity.

The aim of our study was to evaluate the efficacy and toxicity of TECAM (thiotepa, etoposide, cyclophosphamide, cytarabine, and melphalan) and BEAM (carmustine, etoposide, cytarabine, and melphalan) c...

Reduced intensity conditioning with fludarabine, melphalan, and total body irradiation for allogeneic hematopoietic cell transplantation: the effect of increasing melphalan dose on underlying disease and toxicity.

Disease relapse and toxicity are the shortcomings of reduced intensity conditioning (RIC) for allogeneic hematopoietic cell transplantation (alloHCT). We hypothesized that adding total body irradiatio...

Pharmacokinetic-Pharmacodynamic Model of Neutropenia in Patients With Myeloma Receiving High-Dose Melphalan for Autologous Stem Cell Transplant.

High-dose melphalan (HDM) is part of the conditioning regimen in patients with multiple myeloma (MM) receiving autologous stem cell transplantation (ASCT). However, individual sensitivity to melphalan...

Effect of absolute monocyte count post-transplant on the outcome of patients with acute myeloid leukemia undergoing myeloablative allogeneic hematopoietic stem cell transplant with busulfan and cyclophosphamide conditioning.

Peripheral monocytes have recently been evaluated as a prognostic factor in different types of hematological malignancies. This study assessed the prognostic value of absolute monocyte count (AMC) pos...

Reconstituting donor T cells increase their biomass following hematopoietic stem cell transplantation.

In this study, we used a rapid, highly-sensitive, single-cell biomass measurement method, Live Cell Interferometry (LCI), to measure biomass in populations of CD3 + T cells isolated from hematopoietic...

Medical and Biotech [MESH] Definitions

Methods of implanting a CELL NUCLEUS from a donor cell into an enucleated acceptor cell. Often the nucleus of a somatic cell is transferred into a recipient OVUM or stem cell (STEM CELLS) with the nucleus removed. This technology may provide means to generate autologous diploid pluripotent cell for therapeutic cloning, and a model for studying NUCLEAR REPROGRAMMING in embryonic stem cells. Nuclear transfer was first accomplished with frog eggs (RANA PIPIENS) and reported in 1952.

A homeodomain protein and transcription regulator that functions in BLASTOCYST INNER CELL MASS and EMBRYONIC STEM CELL proliferation and CELL SELF RENEWAL. It confers pluripotency on embryonic stem cells and prevents their differentiation towards extraembryonic ENDODERM and trophectoderm (TROPHOBLAST) CELL LINEAGES.

The release of stem cells from the bone marrow into the peripheral blood circulation for the purpose of leukapheresis, prior to stem cell transplantation. Hematopoietic growth factors or chemotherapeutic agents often are used to stimulate the mobilization.

The malignant stem cells of TERATOCARCINOMAS, which resemble pluripotent stem cells of the BLASTOCYST INNER CELL MASS. The EC cells can be grown in vitro, and experimentally induced to differentiate. They are used as a model system for studying early embryonic cell differentiation.

A hematopoietic growth factor and the ligand of the cell surface c-kit protein (PROTO-ONCOGENE PROTEINS C-KIT). It is expressed during embryogenesis and is a growth factor for a number of cell types including the MAST CELLS and the MELANOCYTES in addition to the HEMATOPOIETIC STEM CELLS.

More From BioPortfolio on "Conditioning Regimen in Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Renal Cell Carcinoma
Renal cell cancer (renal adenocarcinoma or hypernephroma) is the most common type of kidney cancer in adults. More than 8 in every 10 (80%) kidney cancers diagnosed in the UK are this type.  In renal cell cancer the cancerous cells start in the lini...

Transplantation
Organ transplantation is the moving of an organ from one body to another or from a donor site to another location on the patient's own body, for the purpose of replacing the recipient's damaged or absent organ. The emerging field of regenerative ...


Searches Linking to this Trial