Palifermin for the Reduction of Oral Mucositis in Single-dose Evaluation (PROMISE)

This study has been completed.
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier:
NCT00109031
First received: April 22, 2005
Last updated: July 13, 2012
Last verified: July 2012
  Purpose

To evaluate whether palifermin (rHuKGF) administered as a single dose is non-inferior to 3 consecutive doses of palifermin in reducing the incidence of severe oral mucositis (World Health Organization [WHO] grade 3 and 4).


Condition Intervention Phase
Cancer
Lymphoma
Leukemia
Drug: palifermin
Drug: Palifermin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: A Randomized, Blinded, Active-control Trial of Palifermin (rHuKGF) to Evaluate Oral Mucositis in Subjects With Hematologic Malignancies Undergoing Fractionated Total Body Irradiation (fTBI) and High Dose Chemotherapy With Autologous Peripheral Blood Progenitor Cell (PBPC) Transplantation

Resource links provided by NLM:


Further study details as provided by Swedish Orphan Biovitrum:

Primary Outcome Measures:
  • Includes incidence of severe oral mucositis (OM), duration of severe OM, Patient-reported outcome (PRO) daily assessments of mouth and throat soreness, use of parenteral or transdermal opioid analgesics [ Time Frame: Up to Day 28 ] [ Designated as safety issue: No ]

Enrollment: 47
Study Start Date: January 2005
Study Completion Date: December 2010
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm C
palifermin 180 mcg/kg 2 days prior to fTBI and placebo the day before and after the 180 mcg/kg dose and palifermin 60 mcg/kg on days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC)
Drug: palifermin
palifermin 180 mcg/kg 2 days prior to fTBI and placebo the day before and after the 180 mcg/kg dose and palifermin 60 mcg/kg on days 0, 1 and 2
Arm D
palifermin 180 mcg/kg 3 days prior to fTBI and placebo the 2 days after the 180 mcg/kg dose and palifermin 60 mcg/kg on days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC)
Drug: palifermin
palifermin 180 mcg/kg 3 days prior to fTBI and placebo the 2 days after the 180 mcg/kg dose and palifermin 60 mcg/kg on days 0, 1 and 2
Arm A
palifermin 60 mcg/kg on the 3 days prior to fTBI and palifermin 60 mcg/kg on days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC)
Drug: palifermin
palifermin 60 mcg/kg on the 3 days prior to fTBI and palifermin 60 mcg/kg on days 0, 1 and 2
Arm B
palifermin 180 mcg/kg 1 day prior to fTBI and placebo on the 2 days prior to the 180 mcg/kg dose and palifermin 60 mcg mcg/kg on days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC)
Drug: Palifermin
palifermin 180 mcg/kg 1 day prior to fTBI and placebo on the 2 days prior to the 180 mcg/kg dose and palifermin 60 mcg mcg/kg on days 0, 1 and 2

  Eligibility

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

Inclusion Criteria:

  • Written informed consent
  • Subjects with: non-Hodgkin's lymphoma, Hodgkin's disease, acute myelogenous leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, chronic lymphocytic leukemia, or multiple myeloma
  • Minimum of 1.5 x 10^6 CD34+ cells/kg cryopreserved and to be transplanted.

Exclusion Criteria:

  • Cancer other than those specified in inclusion criteria above (except: adequately treated basal cell carcinoma of the skin)
  • Prior bone marrow or peripheral blood stem cell transplantation - Negatively selected (purged) stem cell product - Current active infection or oral mucositis
  • Congestive heart failure as defined by New York Heart Association class III or IV.
  • History of or current diagnosis of pancreatitis
  • Inadequate renal function (serum creatinine greater than 1.5x the upper limit of normal per the institutional guidelines)
  • Inadequate liver function (direct bilirubin greater than 1.5x the upper limit of normal, AST greater than 3x upper limit of normal and/or ALT greater than 3x upper limit of normal per the institutional guidelines)
  • Inadequate pulmonary function as measured by a corrected DLCO less than 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 subject is receiving other investigational agent(s)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00109031

Sponsors and Collaborators
Swedish Orphan Biovitrum
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier: NCT00109031     History of Changes
Obsolete Identifiers: NCT00126529, NCT00965692
Other Study ID Numbers: 20040212
Study First Received: April 22, 2005
Last Updated: July 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Swedish Orphan Biovitrum:
Cancer
Oncology

Additional relevant MeSH terms:
Leukemia
Lymphoma
Stomatitis
Mucositis
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Mouth Diseases
Stomatognathic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 27, 2014