Ignite Creation Date:
2024-05-05 @ 11:20 PM
Last Modification Date:
2024-10-26 @ 10:31 AM
Study NCT ID:
NCT01300793
Status:
TERMINATED
Last Update Posted:
2012-09-26
First Post:
2009-09-24
Brief Title:
Study of Standard-Dose Rituximab Ifosfamide Carboplatin and Etoposide
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
RICE Plus Bortezomib Velcade in a Dose-Escalating Fashion for Patients With Relapsed or Primary Refractory Aggressive B-Cell NHL
Status:
TERMINATED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
closed for low accrual and no data is available
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
V-RICE
Brief Summary:
Primary objective of the study is to determine the maximum tolerated dose MTD of bortezomib Velcade in combination with rituximab ifosfamide carboplatin and etoposide for adult patients with relapsed or refractory aggressive B-cell lymphoma The secondary objectives are to assess the tolerability and safety the response rate rate of autologous stem cell transplant and CD34 progenitor cell collection and engraftment after treatment with this regimen
Detailed Description:
Once subjects are determined to be eligible and informed consent is obtainedpatients will be enrolled into a starting dose cohort of 10mgm2 Based upon a satisfactory safety profile additional patients will be enrolled into the 13 15 and 17mgm2 cohorts Each of these dosing cohorts will only be enrolled if satisfactory safety profiles in each of the lower dosing cohorts are obtained As the process continues multiple cohorts will be receiving various dosing regimens simultaneously If a DLT occurs in 2 out of 6 patients at the initial dose level then 3 more patients will be accrued at dose level -1 07mgm2
Bortezomib will be given on days 1 prior to rituximab and 4 rituximab 375 mgm2 on day 1 carboplatin AUC 5 and ifosfamide with mesna each 5 gmm2 on day 3 and etoposide 100 mg m2day on days 2 3 and 4 of a 21-day cycle They will also receive filgrastim on days 6-13 or pegfilgrastim on day 6 Dose-limiting toxicities DLT include any grade 3 or 4 non-hematologic toxicities except alopecia and grade 3 febrile neutropenia grade 4 febrile neutropenia life-threatening sepsis and grade 4 neutropenia persisting past day 35 or grade 3 or 4 thrombocytopenia persisting past day 35
If there is a DLT at a given bortezomib dose level 3 more subjects will be enrolled at that dose if there are 2 or more DLTs then the MTD will be defined as the previous dose level If at that dose level 50 of subjects required bortezomib dose reduction the MTD will be defined as the next lower dose level Subjects will continue to be accrued in order to treat a minimum of 10 patients at the MTD
Those who are candidates for autologous stem cell transplant will have CT scan of the neck chest abdomen and pelvis after 2 cycles Subjects with PD or SD will be taken off study Those with CR PR or response not meeting PR criteria will undergo a total of 3 cycles of bortezomib RICE After the 3rd cycle of bortezomib RICE whole body PETCT scan and bone marrow biopsy will be obtained
Subjects who achieve CR or PR will then proceed to stem cell mobilization and collection by a standard regimen followed by autologous stem cell transplant with a preparative regimen to be determined by the investigator Those with SD or PD will be taken off study While the mobilization and ASCT procedures are not part of the phase I protocol outcomes of ASCT will be followed including CD34 progenitor cell collection clinical response to transplant and survival
Subjects who are not candidates for autologous stem cell transplant will have CT scan of the neck chest abdomen and pelvis after the 2nd and 4th cycles Those who are responding will continue for a maximum of 6 cycles
Bortezomib will be given on days 1 prior to rituximab and 4 rituximab 375 mgm2 on day 1 carboplatin AUC 5 and ifosfamide with mesna each 5 gmm2 on day 3 and etoposide 100 mg m2day on days 2 3 and 4 of a 21-day cycle They will also receive filgrastim on days 6-13 or pegfilgrastim on day 6 Dose-limiting toxicities DLT include any grade 3 or 4 non-hematologic toxicities except alopecia and grade 3 febrile neutropenia grade 4 febrile neutropenia life-threatening sepsis and grade 4 neutropenia persisting past day 35 or grade 3 or 4 thrombocytopenia persisting past day 35
If there is a DLT at a given bortezomib dose level 3 more subjects will be enrolled at that dose if there are 2 or more DLTs then the MTD will be defined as the previous dose level If at that dose level 50 of subjects required bortezomib dose reduction the MTD will be defined as the next lower dose level Subjects will continue to be accrued in order to treat a minimum of 10 patients at the MTD
Those who are candidates for autologous stem cell transplant will have CT scan of the neck chest abdomen and pelvis after 2 cycles Subjects with PD or SD will be taken off study Those with CR PR or response not meeting PR criteria will undergo a total of 3 cycles of bortezomib RICE After the 3rd cycle of bortezomib RICE whole body PETCT scan and bone marrow biopsy will be obtained
Subjects who achieve CR or PR will then proceed to stem cell mobilization and collection by a standard regimen followed by autologous stem cell transplant with a preparative regimen to be determined by the investigator Those with SD or PD will be taken off study While the mobilization and ASCT procedures are not part of the phase I protocol outcomes of ASCT will be followed including CD34 progenitor cell collection clinical response to transplant and survival
Subjects who are not candidates for autologous stem cell transplant will have CT scan of the neck chest abdomen and pelvis after the 2nd and 4th cycles Those who are responding will continue for a maximum of 6 cycles
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