Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-29 @ 5:39 AM
Study NCT ID:
NCT00004061
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
1999-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biological Therapy in Treating Patients Undergoing Radiation Therapy, Chemotherapy, and Peripheral Stem Cell Transplantation for Hematologic Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2009-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 peripheral stem cell transplantation.
PURPOSE: Randomized phase II trial to study the effectiveness of biological therapy to reduce side effects in patients who are undergoing radiation therapy, chemotherapy, and peripheral stem cell transplantation in treating lymphoma or leukemia.
PURPOSE: Randomized phase II trial to study the effectiveness of biological therapy to reduce side effects in patients who are undergoing radiation therapy, chemotherapy, and peripheral stem cell transplantation in treating lymphoma or leukemia.
Detailed Description:
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 15 months.
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 15 months.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: