Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002697
Status:
COMPLETED
Last Update Posted:
2013-07-03
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Plus Radiation Therapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkins Lymphoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
HIGH DOSE CHEMORADIOTHERAPY WITH PERIPHERAL BLOOD PROGENITOR CELL TRANSPLANTATION FOR PATIENTS WITH PRIMARY REFRACTORY RELAPSED AND POOR PROGNOSIS NON-HODGKINS LYMPHOMA
Status:
COMPLETED
Status Verified Date:
2013-07
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining chemotherapy with radiation therapy and peripheral stem cell transplantation may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of high-dose combination chemotherapy plus radiation therapy followed by peripheral stem cell transplantation in patients with refractory or recurrent non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of high-dose combination chemotherapy plus radiation therapy followed by peripheral stem cell transplantation in patients with refractory or recurrent non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the efficacy of mobilization using filgrastim G-CSF with or without standard-dose ifosfamide carboplatin and etoposide ICE conditioning using ifosfamide and etoposide plus total body irradiation or high-dose ICE and autologous peripheral blood stem cell PBSC transplantation as salvage therapy in patients with refractory recurrent or poor prognosis non-Hodgkins lymphoma
Determine the efficacy of reinduction comprising ICE followed by autologous PBSC transplantation in these patients
Determine the ability of standard-dose ICE combined with hematopoietic growth factors to mobilize PBSC in these patients
Determine the contamination of PBSC by lymphoma cells in patients treated with this mobilization regimen
Determine the quality of life of patients treated with this regimen
OUTLINE Patients are stratified according to disease status relapsed vs refractory lymphoma grade low vs intermediate vs high number of extranodal sites serum lactic dehydrogenase performance status age and volume of disease
Mobilizationharvest Patients in first or greater complete remission CR are treated on regimen A whereas patients with recurrent or refractory disease are treated on regimen B
Regimen A Patients with poor prognosis intermediate-grade lymphoma IGL in first CR or IGL or low-grade lymphoma LGL in second or greater CR receive mobilization with filgrastim G-CSF subcutaneously SC daily on days 1-7 Autologous peripheral blood stem cells PBSC are harvested and selected for CD34 cells on days 5 and 6 and day 7 if needed
Regimen B Patients who are currently on the MSKCC standard dose salvage therapy protocol with ifosfamide carboplatin and etoposide ICE for recurrent or refractory IGL receive additional mobilization with G-CSF after completion of the last course of ICE Patients with recurrent or refractory IGL immunoblastic lymphoma or LGL who have not previously received ifosfamide and are not currently on the MSKCC standard dose salvage protocol with ICE receive ifosfamide IV and carboplatin on day 2 and etoposide IV on days 1-3 standard-dose ICE followed by G-CSF SC When blood counts recover autologous PBSC are harvested and selected for CD34 cells
Regimens A and B If additional hematopoietic growth factors HGFs become available they may be administered concurrently with G-CSF If inadequate CD34 cells are collected then autologous bone marrow is harvested
Conditioning Patients who are under age 60 and have not received dose-limiting radiotherapy are treated on regimen C Patients who are age 60 and over and patients who are under age 60 and have received dose-limiting radiotherapy are treated on regimen D
Regimen C Patients undergo hyperfractionated total body irradiation twice a day on days -10 to -7 and ifosfamide IV over 1 hour followed by etoposide IV over 23 hours on days -6 to -2
Regimen D Patients receive ifosfamide IV over 1 hour followed by etoposide IV over 11 hours followed by carboplatin IV over 1 hour followed by etoposide IV over 11 hours on days -7 to -3 high-dose ICE
Regimens C and D Patients with residual or relapsed disease may undergo boost radiotherapy twice a day 5 days a week for 1-2 weeks before conditioning or after transplantation
Transplantation PBSC or bone marrow is reinfused on day 0 Patients receive G-CSF SC every 12 hours beginning on day 1 and continuing until blood counts recover If additional HGFs become available they may be administered concurrently with G-CSF
Quality of life is assessed at baseline and then at 6 12 and 24 months after transplantation
Patients are followed at 1 and 3 months every 3 months through year 2 every 4 months through year 5 and then every 6 months thereafter
PROJECTED ACCRUAL A total of 80 patients 20 for regimen A and 60 for regimen B will be accrued for this study
Determine the efficacy of mobilization using filgrastim G-CSF with or without standard-dose ifosfamide carboplatin and etoposide ICE conditioning using ifosfamide and etoposide plus total body irradiation or high-dose ICE and autologous peripheral blood stem cell PBSC transplantation as salvage therapy in patients with refractory recurrent or poor prognosis non-Hodgkins lymphoma
Determine the efficacy of reinduction comprising ICE followed by autologous PBSC transplantation in these patients
Determine the ability of standard-dose ICE combined with hematopoietic growth factors to mobilize PBSC in these patients
Determine the contamination of PBSC by lymphoma cells in patients treated with this mobilization regimen
Determine the quality of life of patients treated with this regimen
OUTLINE Patients are stratified according to disease status relapsed vs refractory lymphoma grade low vs intermediate vs high number of extranodal sites serum lactic dehydrogenase performance status age and volume of disease
Mobilizationharvest Patients in first or greater complete remission CR are treated on regimen A whereas patients with recurrent or refractory disease are treated on regimen B
Regimen A Patients with poor prognosis intermediate-grade lymphoma IGL in first CR or IGL or low-grade lymphoma LGL in second or greater CR receive mobilization with filgrastim G-CSF subcutaneously SC daily on days 1-7 Autologous peripheral blood stem cells PBSC are harvested and selected for CD34 cells on days 5 and 6 and day 7 if needed
Regimen B Patients who are currently on the MSKCC standard dose salvage therapy protocol with ifosfamide carboplatin and etoposide ICE for recurrent or refractory IGL receive additional mobilization with G-CSF after completion of the last course of ICE Patients with recurrent or refractory IGL immunoblastic lymphoma or LGL who have not previously received ifosfamide and are not currently on the MSKCC standard dose salvage protocol with ICE receive ifosfamide IV and carboplatin on day 2 and etoposide IV on days 1-3 standard-dose ICE followed by G-CSF SC When blood counts recover autologous PBSC are harvested and selected for CD34 cells
Regimens A and B If additional hematopoietic growth factors HGFs become available they may be administered concurrently with G-CSF If inadequate CD34 cells are collected then autologous bone marrow is harvested
Conditioning Patients who are under age 60 and have not received dose-limiting radiotherapy are treated on regimen C Patients who are age 60 and over and patients who are under age 60 and have received dose-limiting radiotherapy are treated on regimen D
Regimen C Patients undergo hyperfractionated total body irradiation twice a day on days -10 to -7 and ifosfamide IV over 1 hour followed by etoposide IV over 23 hours on days -6 to -2
Regimen D Patients receive ifosfamide IV over 1 hour followed by etoposide IV over 11 hours followed by carboplatin IV over 1 hour followed by etoposide IV over 11 hours on days -7 to -3 high-dose ICE
Regimens C and D Patients with residual or relapsed disease may undergo boost radiotherapy twice a day 5 days a week for 1-2 weeks before conditioning or after transplantation
Transplantation PBSC or bone marrow is reinfused on day 0 Patients receive G-CSF SC every 12 hours beginning on day 1 and continuing until blood counts recover If additional HGFs become available they may be administered concurrently with G-CSF
Quality of life is assessed at baseline and then at 6 12 and 24 months after transplantation
Patients are followed at 1 and 3 months every 3 months through year 2 every 4 months through year 5 and then every 6 months thereafter
PROJECTED ACCRUAL A total of 80 patients 20 for regimen A and 60 for regimen B will be accrued for this study
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V95-0784 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000064483 | REGISTRY | None | None |