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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

This study has been completed.
Study NCT00041665.   Last updated on December 20, 2007.   Information provided by Amgen

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Descriptive Information Fields
Brief Title  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
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
Brief Summary

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.

Detailed Description
Study Phase Phase III
Study Type  Interventional
Study Design  Prevention, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Stomatitis
Intervention  Drug: Recombinant Human Keratinocyte Growth Factor
MEDLINE PMIDs 16391299,   17580258,   16415901
Links AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date 
Completion Date
Eligibility 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.

Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries 
Administrative Information Fields
NCT ID  NCT00041665
Organization ID 20000162
Secondary IDs †† NLM Identifier NCT00020813, UCLA-0012064, MSKCC-01065, FHCRC-161200
Study Sponsor  Amgen
Collaborators ††
Investigators 
Study Director:     MD     Amgen    
Information Provided By Amgen
Verification Date December 2007
First Received Date  July 11, 2002
Last Updated Date December 20, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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