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
OBJECTIVES: I. Determine the efficacy of recombinant human keratinocyte growth factor
(rHuKGF) in reducing severe oral mucositis induced by total body irradiation and high dose
chemotherapy in patients with hematologic malignancies. II. Compare the incidence of severe
oral mucositis, the use of transdermal or perenteral opioid analgesics, and the incidence
and duration of grade 2-4 diarrhea with or without rHuKGF in these patients. III. Determine
the quality of life of these patients. IV. Determine the duration of febrile neutropenia and
the duration of treatment with intravenous antifungals or antibiotics in these patients.
OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients
are stratified according to center. Patients are randomized to one of three treatment arms.
Arm I: Patients receive recombinant human keratinocyte growth factor (rHuKGF) IV on days -11
to -9, -5, and 0 to 2. Total body irradiation (TBI) is administered twice a day on days -8
to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 1
hour on day -2 (some patients may receive an alternate regimen of ifosfamide IV over 1 hour
on days-4 to 0 followed each day by etoposide IV over 23 hours). Filgrastim (G-CSF) is
administered subcutaneously (SQ) beginning on day 0 and continuing for up to 21 days until
blood counts recover. Autologous peripheral blood stem cells (PBSC) are infused on day 0.
Arm II: Patients receive rHuKGF on days -11 to -9 and -5 as in arm I. Placebo is
administered on days 0 to 2. TBI, chemotherapy, and PBSC transplantation are administered as
in arm I. Arm III: Patients receive placebo on days -11 to -9, -5, and 0 to 2. TBI,
chemotherapy, and PBSC transplantation are administered as in arm I. Quality of life is
assessed prior to treatment, daily during therapy and until day 28 after transplantation.
Patients are followed at day 28 and approximately day 60-100.
PROJECTED ACCRUAL: At least 111 patients (37 per arm) will be accrued for this study within
Allocation: Randomized, Primary Purpose: Supportive Care
Eric W. Hedrick, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
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