Track topics on Twitter Track topics that are important to you
RATIONALE: Keratinocyte growth factor may prevent symptoms of mucositis in patients receiving radiation therapy and chemotherapy.
PURPOSE: Randomized phase II trial to study the effectiveness of keratinocyte growth factor in preventing oral mucositis in patients who have hematologic cancers and who are undergoing radiation therapy and chemotherapy before autologous peripheral stem cell transplantation.
OBJECTIVES: I. Determine the efficacy of recombinant keratinocyte growth factor in reducing the duration of severe oral mucositis induced by total body irradiation and high dose chemotherapy in patients with hematologic malignancies. II. Determine the incidence and duration of severe oral mucositis, grade 2-4 diarrhea, and febrile neutropenia in these patients. III. Determine the necessity of use of transdermal or parenteral opioid analgesics and IV antifungals or antibiotics for febrile neutropenia or infections in these patients. IV. Determine the quality of life of these patients.
OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified by center. Patients are randomized to one of three treatment arms. Arm I: Patients receive 7 doses of recombinant human keratinocyte growth factor (rHuKGF). Arm II: Patients receive 4 doses of rHuKGF followed by 3 doses of placebo. Arm III: Patients receive 7 doses of placebo. Patients receive one of two conditioning regimens. Primary conditioning regimen: Patients receive rHuKGF or placebo daily on days -11, -10, -9, -5, 0, 1, and 2. Total body irradiation (TBI) is administered twice a day on days -8 to -5. Patients receive etoposide on day -4, cyclophosphamide IV over 1 hour on day -2, and peripheral blood stem cell transplantation (PBSCT) on day 0. Filgrastim (G-CSF) IV or SC is administered beginning on day 0 and continuing for 21 days or until blood counts recover. Secondary conditioning regimen: Patients receive rHuKGF or placebo daily on days -13, -12, -11, -7, 0, 1, and 2. TBI is administered twice a day on days -10 to -7. Patients receive ifosfamide IV over 1 hour followed by etoposide over 23 hours on days -6 to -2, then PBSCT on day 0. G-CSF IV or SC is administered beginning on day 0 for 21 days or until blood counts recover. Quality of life is assessed daily beginning on day -11 and continuing until day 28. Patients are followed at day 28 and then at day 60-100.
PROJECTED ACCRUAL: A minimum of 111 patients (37 per arm) will be accrued for this study.
Allocation: Randomized, Primary Purpose: Supportive Care
Drug/Agent Toxicity by Tissue/Organ
filgrastim, palifermin, cyclophosphamide, etoposide, ifosfamide, quality-of-life assessment, radiation therapy
Jonsson Comprehensive Cancer Center, UCLA
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:58:21-0400
RATIONALE: Biological therapy using growth factors may be effective in reducing side effects in patients who have hematologic cancer and are receiving radiation therapy, chemotherapy, and ...
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim or filgrastim-SD/01 ma...
Primary: 1. To evaluate the preliminary efficacy of palifermin in reducing the incidence and severity of oral mucositis (OM) in patients with sarcoma receiving multicycle ...
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 ...
RATIONALE: Chemotherapy drugs, such as ifosfamide, carboplatin, and etoposide, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies ...
Introduction: The relevance of study, assessment and prediction of the life quality of patients with chronic pancreatitis to improve the provision of medical care and rehabilitation is high, since it ...
To assess health-related quality of life (HRQoL) and its associated factors among people living with HIV/AIDS (PLWHA) in Rio de Janeiro, Brazil.
Health-related quality of life (HRQoL) acquires increased importance as a target parameter for different stakeholders in healthcare, e. g. to assess treatment outcome in chronically ill patients. In...
Consideration of quality of life has developed into an important concept of a patient-oriented medicine in the last 50 years. With it, it should be possible to capture the subjective experience of the...
The simultaneous measurement of the concentration of anticancer drugs with a fast, sensitive and accurate method in biological samples is a challenge for better monitoring of drug therapy and better d...
A sulfhydryl compound used to prevent urothelial toxicity by inactivating metabolites from ANTINEOPLASTIC AGENTS, such as IFOSFAMIDE or CYCLOPHOSPHAMIDE.
Positional isomer of CYCLOPHOSPHAMIDE which is active as an alkylating agent and an immunosuppressive agent.
A semisynthetic derivative of PODOPHYLLOTOXIN that exhibits antitumor activity. Etoposide inhibits DNA synthesis by forming a complex with topoisomerase II and DNA. This complex induces breaks in double stranded DNA and prevents repair by topoisomerase II binding. Accumulated breaks in DNA prevent entry into the mitotic phase of cell division, and lead to cell death. Etoposide acts primarily in the G2 and S phases of the cell cycle.
A major cytochrome P-450 enzyme which is inducible by PHENOBARBITAL in both the LIVER and SMALL INTESTINE. It is active in the metabolism of compounds like pentoxyresorufin, TESTOSTERONE, and ANDROSTENEDIONE. This enzyme, encoded by CYP2B1 gene, also mediates the activation of CYCLOPHOSPHAMIDE and IFOSFAMIDE to MUTAGENS.
A measurement index derived from a modification of standard life-table procedures and designed to take account of the quality as well as the duration of survival. This index can be used in assessing the outcome of health care procedures or services. (BIOETHICS Thesaurus, 1994)
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Organ transplantation is the moving of an organ from one body to another or from a donor site to another location on the patient's own body, for the purpose of replacing the recipient's damaged or absent organ. The emerging field of regenerative ...