Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004061
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
1999-12-10
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:
National Cancer Institute NCI
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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G99-1574 | Registry Identifier | PDQ Physician Data Query | None |
| MSKCC-99029 | None | None | None |
| CDR0000067261 | REGISTRY | None | None |