Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002649
Status:
COMPLETED
Last Update Posted:
2013-02-28
First Post:
1999-11-01
Brief Title:
Interleukin-2 or Observation Following Radiation Therapy Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Non-Hodgkins Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Total Body Irradiation Etoposide Cyclophosphamide and Autologous Peripheral Blood Stem Cell Transplantation Followed by Randomization to Therapy With Interleukin-2 Versus Observation for Patients With Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2013-02
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:
Randomized phase III trial to compare the effectiveness of interleukin-2 with that of observation following radiation therapy combination chemotherapy and peripheral stem cell transplantation in treating patients who have refractory or relapsed non-Hodgkins lymphoma Interleukin-2 may stimulate a persons white blood cells to kill non-Hodgkins lymphoma cells Giving interleukin-2 after radiation therapy chemotherapy and peripheral stem cell transplantation may kill more cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I To compare the survival and disease-free survival of patients with non-Hodgkins lymphoma treated with post-transplant therapy with interleukin-2 IL-2 or no further treatment Transplant therapy is total body irradiation TBI high-dose etoposide cyclophosphamide and peripheral blood stem cell transplant PBSCT
II To assess the frequency and severity of toxicity associated with post-transplant IL-2 therapy
OUTLINE This is a randomized multicenter study Patients are stratified according to disease grade low vs intermediate vs high chemosensitive disease yes vs no partial or complete response after initial induction chemotherapy yes vs no and performance status 0-1 vs 2
Part I Autologous peripheral blood stem cells PBSC are harvested before study entry Patients undergo total body irradiation twice a day on days -8 to -5 high-dose etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 1 hour on day -2 PBSC are reinfused on day 0 and then filgrastim G-CSF may be administered subcutaneously or IV on days 0-21
Part II Within 28-80 days after PBSC transplantation and after recovery from any toxic effects patients with no active recurrent or progressive disease are randomized to 1 of 2 treatment arms
Arm I Patients receive interleukin-2 IV continuously on days 1-4 and 9-18
Arm II Patients undergo observation only
Patients are followed every 3 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL Approximately 275 patients will be accrued for this study within 35-59 years
I To compare the survival and disease-free survival of patients with non-Hodgkins lymphoma treated with post-transplant therapy with interleukin-2 IL-2 or no further treatment Transplant therapy is total body irradiation TBI high-dose etoposide cyclophosphamide and peripheral blood stem cell transplant PBSCT
II To assess the frequency and severity of toxicity associated with post-transplant IL-2 therapy
OUTLINE This is a randomized multicenter study Patients are stratified according to disease grade low vs intermediate vs high chemosensitive disease yes vs no partial or complete response after initial induction chemotherapy yes vs no and performance status 0-1 vs 2
Part I Autologous peripheral blood stem cells PBSC are harvested before study entry Patients undergo total body irradiation twice a day on days -8 to -5 high-dose etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 1 hour on day -2 PBSC are reinfused on day 0 and then filgrastim G-CSF may be administered subcutaneously or IV on days 0-21
Part II Within 28-80 days after PBSC transplantation and after recovery from any toxic effects patients with no active recurrent or progressive disease are randomized to 1 of 2 treatment arms
Arm I Patients receive interleukin-2 IV continuously on days 1-4 and 9-18
Arm II Patients undergo observation only
Patients are followed every 3 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL Approximately 275 patients will be accrued for this study within 35-59 years
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 |
|---|---|---|---|
| SWOG-9438 | None | None | None |
| U10CA032102 | NIH | None | None |
| CDR0000064175 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA032102 |