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.

Condition	Treatment or Intervention	Phase
Stomatitis	Drug: Recombinant Human Keratinocyte Growth Factor	Phase III

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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 > or = 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.

California
      Research Center, Duarte,  California,  United States
      Research Center, Los Angeles,  California,  United States
District of Columbia
      Research Center, Washington,  District of Columbia,  United States
Illinois
      Research Center, Maywood,  Illinois,  United States
Maryland
      Research Center, Baltimore,  Maryland,  United States
Minnesota
      Research Center, Minneapolis,  Minnesota,  United States
New York
      Research Center, New York,  New York,  United States
      Research Center, Syracuse,  New York,  United States
North Carolina
      Research Center, Chapel Hill,  North Carolina,  United States
Oregon
      Research Center, Portland,  Oregon,  United States
Texas
      Research Center, San Antonio,  Texas,  United States
Virginia
      Research Center, Richmond,  Virginia,  United States
Washington
      Research Center, Seattle,  Washington,  United States

Study ID Numbers:  20000162; NLM Identifier NCT00020813; UCLA-0012064; MSKCC-01065; FHCRC-161200
Record last reviewed:  January 2003
Last Updated:  October 13, 2004
Record first received:  July 11, 2002
ClinicalTrials.gov Identifier:  NCT00041665
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08