Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00233987
Status:
COMPLETED
Last Update Posted:
2018-03-01
First Post:
2005-10-05
Brief Title:
S0410 Tandem Stem Cell Transplantation in Treating Patients With Progressive or Recurrent Hodgkins Lymphoma
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Tandem Autologous Stem Cell Transplantation for Patients With Primary Progressive or Recurrent Hodgkins Disease A BMT Study Phase II
Status:
COMPLETED
Status Verified Date:
2018-01
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 Radiation therapy uses high-energy x-rays to kill cancer cells Drugs used in chemotherapy work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving chemotherapy with a peripheral stem cell transplant may allow more chemotherapy to be given so that more cancer cells are killed Tandem two autologous stem cell transplants may be an effective treatment for Hodgkins lymphoma
PURPOSE This phase II trial is studying how well tandem stem cell transplantation works in treating patients with progressive or recurrent Hodgkins lymphoma
PURPOSE This phase II trial is studying how well tandem stem cell transplantation works in treating patients with progressive or recurrent Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the 2-year progression-free survival of patients with progressive or recurrent Hodgkins lymphoma treated with tandem autologous stem cell transplantation 2 courses of high-dose therapy with autologous stem cell rescue
Determine the response rate in patients treated with this regimen
Determine the toxic effects of this regimen in these patients
OUTLINE This is a multicenter study
Salvage therapy for patients with relapsed disease after achieving a previous complete response Patients receive at least 2 courses of salvage chemotherapy or radiotherapy No more than 6 weeks later patients proceed to autologous hematopoietic stem cell collection
Autologous hematopoietic stem cell collection Patients undergo autologous hematopoietic stem cell collection Patients with an inadequate number of collected stem cells are removed from the study
Pre-transplant salvage radiation Patients with residual tumor greater than 5 cm after initial salvage therapy undergo involved-field radiotherapy All patients then proceed to the first preparative regimen
First preparative regimen Patients receive high-dose melphalan IV on day -1
First autologous stem cell transplantation SCT Patients undergo autologous SCT on day 0 At least 28 days later patients proceed to second preparative regimen
Second preparative regimen Patients receive 1 of the following preparative regimens
Total-body irradiation TBI-based regimen Patients undergo TBI twice daily on days -8 to -5 Patients also receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 1 hour on day -2
Carmustine-based regimen Patients receive carmustine IV over 2 hours on days -6 to -4 etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 1 hour on day -2
Second autologous SCT Patients undergo second autologous SCT on day 0 After completion of study treatment patients are followed every 6 months for 2 years and then annually for up to 7 years
PROJECTED ACCRUAL A total of 85 patients will be accrued for this study over 2 years
Determine the 2-year progression-free survival of patients with progressive or recurrent Hodgkins lymphoma treated with tandem autologous stem cell transplantation 2 courses of high-dose therapy with autologous stem cell rescue
Determine the response rate in patients treated with this regimen
Determine the toxic effects of this regimen in these patients
OUTLINE This is a multicenter study
Salvage therapy for patients with relapsed disease after achieving a previous complete response Patients receive at least 2 courses of salvage chemotherapy or radiotherapy No more than 6 weeks later patients proceed to autologous hematopoietic stem cell collection
Autologous hematopoietic stem cell collection Patients undergo autologous hematopoietic stem cell collection Patients with an inadequate number of collected stem cells are removed from the study
Pre-transplant salvage radiation Patients with residual tumor greater than 5 cm after initial salvage therapy undergo involved-field radiotherapy All patients then proceed to the first preparative regimen
First preparative regimen Patients receive high-dose melphalan IV on day -1
First autologous stem cell transplantation SCT Patients undergo autologous SCT on day 0 At least 28 days later patients proceed to second preparative regimen
Second preparative regimen Patients receive 1 of the following preparative regimens
Total-body irradiation TBI-based regimen Patients undergo TBI twice daily on days -8 to -5 Patients also receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 1 hour on day -2
Carmustine-based regimen Patients receive carmustine IV over 2 hours on days -6 to -4 etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 1 hour on day -2
Second autologous SCT Patients undergo second autologous SCT on day 0 After completion of study treatment patients are followed every 6 months for 2 years and then annually for up to 7 years
PROJECTED ACCRUAL A total of 85 patients will be accrued for this study over 2 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 |
|---|---|---|---|
| U10CA032102 | NIH | None | None |
| S0410 | OTHER | SWOG | httpsreporternihgovquickSearchU10CA032102 |