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Stem Cell Transplant for Hematologic Diseases and Renal Cell Cancer
Basic Trial Information
Summary Usually, patients are given very strong doses of chemotherapy (drugs which kill cancer cells) prior to receiving a stem cell transplant. However some patients, due to complications with their condition, may have a high risk of getting possibly life-threatening treatment-related side effects. Recently, investigators have developed an increased interest in using chemotherapy that does not cause as many side effects (less toxic) before patients receive a transplant. The major problem with this type of chemotherapy is that there is a greater chance of having graft versus host disease (GVHD). GVHD occurs when the new stem cells from the donor (graft) recognizes that the body tissues of the patient (host) are different. When this happens cells in the graft may attack the host organs, primarily the skin, the liver and the intestines. This research study adds CAMPATH 1H to a low-dose chemotherapy regimen (the pattern that the treatment is administered) followed by allogeneic stem cell transplantation. This research study will help us learn if the addition of CAMPATH 1H to the pre-transplant low dose chemotherapy will decrease the known side effects from an allogeneic stem cell transplantation, while providing a curative treatment to patients with blood disorders and renal cell cancer. Further Study Information Before treatment begins, stem cells will be collected from the donor's blood or bone marrow. The stem cells will be collected and frozen before we start to give the patient chemotherapy. After admission to the hospital, patients will receive total body irradiation (very strong type of x-rays that kill cells in the bone marrow), Fludarabine and Campath 1H prior to the Stem cell transplant (infusion of the donors stem cells). Starting 7 days after the transplant, the patient will be given G-CSF by subcutaneous injection until a blood test shows that granulocytes (a type of white blood cell) are more than 1000/ul. This is to help increase blood counts. After transplantation, the patient will have several evaluations at different times. These are standard evaluations and tests done for any patient who has received a stem cell transplant as part of routine clinical monitoring: We will also be looking at the patient's immune function (how the body protects itself to prevent and fight infections and diseases). To do this blood tests will be done at regular intervals (every 3 to 6 months) for 2 years. Depending on how well the donors stem cells work in the body after the transplant, the patient may receive one or more Donor Leukocyte Infusions (DLI). This is when leukocytes (a type of white blood cell) collected from the same donor that provided the stem cells are given to the patient through a central line into a vein. Eligibility Criteria Eligibility Criteria:
Exclusion Criteria:
Trial Lead Organizations/Sponsors Dan L. Duncan Cancer Center at Baylor College of Medicine
Trial Sites
Link to the current ClinicalTrials.gov record. Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov. Back to Top |
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