Malignant Melanoma Clinical Trial
Official title:
Immunoablative Protocol for Allogeneic Related and Unrelated Hematopoietic Peripheral Blood Stem Cell Transplant (HPBSC)
The purpose of this research study is to evaluate the effectiveness of transplantation of high doses of peripheral blood stem cells (stem cells are special cells found in the blood and bone marrow that produce new blood cells) after treatment with non-myeloablative chemotherapy (not toxic to the bone marrow). In addition, this study will assess the side effects of the transplant.
The standard treatment in many disorders of the bone marrow is high dose chemotherapy and
whole-body radiation treatment followed by the stem cell transplant. This type of transplant
not only suppresses or kills off the immune system, but is very toxic to the bone marrow.
This study uses a chemotherapy regimen that will suppress the patient's immune system;
however, it is non-myeloablative (not toxic to the bone marrow). It does not use whole-body
radiation treatment. This approach can minimize the short- and long-term effects of
transplantation. Other studies have shown that using chemotherapy followed by bone marrow
transplantation without whole-body radiation can produce similar results as treatment with
whole-body radiation.
Patients will be given chemotherapy with Fludarabine and Busulfan prior to the stem cell
transplant. This treatment not only destroys diseased cells, but it also kills normal bone
marrow cells. Following this experimental treatment, the patient will be given the stem cells
through a central venous catheter (tube inserted in a vein). When the healthy stem cells are
given to the patient, they will replace the destroyed bone marrow cells and produce new blood
cells. The Allogeneic (not one's own) stem cells used in this experimental transplant will be
obtained from a related matched donor or from an unrelated matched donor located through the
National Marrow Donor Program.
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