A Randomized, Double-Blind, Placebo-Controlled Trial of Recombinant Human Keratinocyte Growth Factor (rHuKGF) in Patients With Hematologic Malignancies Undergoing Total Body Irradiation (TBI) and High-Dose Chemotherapy With Autologous Peripheral Blood Progenitor Cell (PBPC) 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
Christos E. Emmanouilides, MD
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|