Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004132
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
1999-12-10
Brief Title:
Growth Factor to Prevent Oral Mucositis in Patients With Hematologic Cancer
Sponsor:
Jonsson Comprehensive 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 Progenitor Cell PBPC Transplantation
Status:
COMPLETED
Status Verified Date:
2007-06
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 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
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
Detailed Description:
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
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
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-G99-1609 | Registry Identifier | PDQ Physician Data Query | None |
| UCLA-9812041 | None | None | None |
| CDR0000067362 | REGISTRY | None | None |