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

May 6, 2013 updated by: Amgen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

July 11, 2002

First Submitted That Met QC Criteria

July 12, 2002

First Posted (Estimate)

July 15, 2002

Study Record Updates

Last Update Posted (Estimate)

May 8, 2013

Last Update Submitted That Met QC Criteria

May 6, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20000162
  • NLM Identifier NCT00020813
  • UCLA-0012064
  • MSKCC-01065
  • FHCRC-161200

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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