Recombinant Human Keratinocyte Growth Factor to Reduce Oral Mucositis in Hematologic Malignancy Patients Undergoing Peripheral Blood Stem Cell Transplantation After Radiation and High-dose Chemotherapy
Recombinant Human Keratinocyte Growth Factor to Reduce Oral Mucositis in Hematologic Malignancy Patients Undergoing Peripheral Blood Stem Cell Transplantation After Radiation and High-dose Chemotherapy
Radiotherapy and high dose chemotherapy with bone marrow transplantation or peripheral blood
 stem cell transplantation is frequently used as treatment for patients with cancers of the
 bone marrow or lymph nodes such as Hodgkin's disease, non-Hodgkin's lymphoma, leukemia or
 multiple myeloma. A common side effect of the radiotherapy and high dose chemotherapy is
 mucositis (inflammation of the inside of the mouth and throat resulting in pain and
 difficulty swallowing). Mucositis is often very severe such that patients receive intravenous
 nutrition and pain medication in the hospital.

 In this study, an investigational recombinant human growth factor called Keratinocyte Growth
 Factor (rHuKGF) is being evaluated to determine its protective effect on the mucosal tissue
 and its ability to reduce the mouth and throat soreness.
Inclusion Criteria: * Patients with: non-Hodgkin's lymphoma, Hodgkin's disease, acute
 myelogenous leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, chronic
 lymphocytic leukemia, or multiple myeloma * Eligible for fractionated total body
 irradiation (fTBI) plus high-dose chemotherapy followed by autologous PBPC support. * 18
 years of age or older * Karnofsky performance status greater than or equal to 70% * Minimum
 of 1.5 Mio CD34+ cells/kg cryopreserved and to be transplanted * Informed consent for
 participation in the study Exclusion Criteria: * History of, or concurrent cancer other
 than NHL, Hodgkin's disease, AML, ALL, CML, CLL, multiple myeloma * Prior bone marrow or
 peripheral blood stem cell transplantation * Purged stem cell product * Currently active
 infection or oral mucositis * Congestive heart failure * Serum creatinine > 1.5x ULN *
 Direct bilirubin > 1.5x ULN * Transaminases > 3x ULN * Corrected DLCO < 50% of predicted *
 Subject is currently enrolled in, or has not yet completed at least 30 days since ending
 other investigational device or drug trial(s) or is receiving other investigational
 agent(s). * Subject is pregnant (eg, positive human chorionic gonadotropin [HCG] test) or
 is breastfeeding. * Subject refuses to use adequate contraceptive precautions. * Known
 hypersensitivity to any of the products to be administered during dosing, including E
 coli-derived products. * Inability to give a truly informed consent.