A Randomized Study of the Site for Growth Factor Injection for Patients Undergoing Autologous Stem Cell Transplantation

A Phase II Single Institution Randomized Study Comparing Cytokine Administration Sites for Mobilization of Peripheral Hematopoietic Progenitor Cells for Patients Undergoing Autologous Hematopoietic Progenitor Cell Transplant

The purpose of this study is to determine whether or not the injection site of cytokines, or growth factors, has an effect on peripheral blood stem cell collection.

The purpose of this study is to determine the preferred injection site for G-CSF and GM-CSF, which are cytokines, or growth factors. The doctor may also choose to use these growth factors in combination with chemotherapy to increase the number of stem cells in the blood. Both options are established and are effective in increasing the number of stem cells in the blood.

Patients will receive one shot under the skin twice a day for approximately 12-15 days after receiving chemotherapy through the time your cells are being collected. Patients will be randomly assigned to receive growth factors administered either to their abdomen or to their extremities. Both shots will always be given either in the abdomen or in the extremities.

Inclusion Criteria:

• All patients undergoing autologous peripheral blood stem cell transplant (PBSC) for relapsed/refractory Hodgkin's disease, non-Hodgkin's lymphoma, or patients with myeloma. All patients must meet criteria for transplantation.

Exclusion Criteria:

• Patients with active, invasive/systemic fungal infection.
• Patients who are pregnant or lactating females.
• Patients with active CNS malignant disease or life expectancy limited by diseases other than the disease for which the patient is being transplanted.
• Also, patients cannot have known hypersensitivity to either G-CSF or GM-CSF.