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 - Full Text View

Sponsor:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00041665

Purpose

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	Intervention	Phase
Stomatitis	Drug: Recombinant Human Keratinocyte Growth Factor	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
Official Title:	A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of Recombinant Human Keratinocyte Growth Factor for Reduction of Mucositis in Patients With Hematologic Malignancies Undergoing Total Body Irradiation and High-Dose Chemotherapy With Autologous PBPC Transplantation

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Fibroblast growth factor 7 Palifermin

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00041665

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Publications:

Stiff PJ, Emmanouilides C, Bensinger WI, Gentile T, Blazar B, Shea TC, Lu J, Isitt J, Cesano A, Spielberger R. Palifermin reduces patient-reported mouth and throat soreness and improves patient functioning in the hematopoietic stem-cell transplantation setting. J Clin Oncol. 2006 Nov 20;24(33):5186-93. Epub 2006 Jan 3.

Elting LS, Shih YC, Stiff PJ, Bensinger W, Cantor SB, Cooksley C, Spielberger R, Emmanoulides C. Economic impact of palifermin on the costs of hospitalization for autologous hematopoietic stem-cell transplant: analysis of phase 3 trial results. Biol Blood Marrow Transplant. 2007 Jul;13(7):806-13. Epub 2007 Apr 23.

Stiff PJ, Erder H, Bensinger WI, Emmanouilides C, Gentile T, Isitt J, Lu ZJ, Spielberger R. Reliability and validity of a patient self-administered daily questionnaire to assess impact of oral mucositis (OM) on pain and daily functioning in patients undergoing autologous hematopoietic stem cell transplantation (HSCT). Bone Marrow Transplant. 2006 Feb;37(4):393-401.

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20000162, NLM Identifier NCT00020813, UCLA-0012064, MSKCC-01065, FHCRC-161200
Study First Received:	July 11, 2002
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00041665 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Mouth Diseases
Molecular Mechanisms of Pharmacological Action
Stomatitis
Mucositis
Hematologic Neoplasms
Gastrointestinal Diseases
Hematologic Diseases
Mitosis Modulators

Pharmacologic Actions
Neoplasms
Digestive System Diseases
Neoplasms by Site
Mitogens
Stomatognathic Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on November 20, 2009