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Sponsored by: |
Baylor College of Medicine |
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Information provided by: | Baylor College of Medicine |
ClinicalTrials.gov Identifier: | NCT00058825 |
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.
Condition | Intervention | Phase |
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Hematologic Malignancies |
Biological: Campath 1H Drug: Fludarabine Procedure: Stem Cell Transplant Radiation: TBI |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Study of Allogeneic Stem Cell Transplantation for Patients With Hematologic Diseases and Renal Cell Carcinoma, Using Haploidentical Family Donors and Sub-Myeloablative Conditioning With Campath 1H |
Estimated Enrollment: | 20 |
Study Start Date: | August 2000 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | up to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Eligibility Criteria:
Conditions that increase Treatment Related Mortality (need one or more to be eligible):
Exclusion Criteria:
Contact: George Carrum, MD | 713-394-6252 | gcarrum@bcm.tmc.edu |
United States, Texas | |
Texas Children's Hospital | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: George Carrum, MD 713-394-6252 gcarrum@bcm.tmc.edu | |
The Methodist Hospital | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: George Carrum, MD 713-394-6252 gcarrum@bcm.tmc.edu | |
Principal Investigator: George Carrum, MD |
Study Director: | Malcolm K Brenner, MD | Center for Cell and Gene Therapy |
Responsible Party: | Baylor College of Medicine ( George Carrum, MD ) |
Study ID Numbers: | H8713 |
Study First Received: | April 11, 2003 |
Last Updated: | May 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00058825 |
Health Authority: | United States: Food and Drug Administration |
Hematologic Neoplasms Hematologic Diseases Alemtuzumab Carcinoma, Renal Cell Fludarabine |
Fludarabine monophosphate Renal cancer Kidney cancer Carcinoma |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site Molecular Mechanisms of Pharmacological Action Immunologic Factors |
Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |