Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002521
Status:
COMPLETED
Last Update Posted:
2010-10-01
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy and Bone Marrow andor Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkins Lymphoma
Sponsor:
Temple University
Organization:
Temple University
Study Overview
Official Title:
HIGH-DOSE CYCLOPHOSPHAMIDE ETOPOSIDE AND CISPLATIN CEP WITH RESCUE BY AUTOLOGOUS BONE MARROW OR AUTOLOGOUS PERIPHERAL BLOOD STEM CELLS IN PATIENTS WITH RELAPSED OR REFRACTORY NON-HODGKINS LYMPHOMA INTERMEDIATE AND HIGH-GRADE HISTOLOGIES
Status:
COMPLETED
Status Verified Date:
2010-09
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 Bone marrow and peripheral stem cell transplantation may allow doctors to give high doses of chemotherapy and kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy with cyclophosphamide etoposide and cisplatin followed by bone marrow andor peripheral stem cell transplantation in patients with relapsed or refractory intermediate- or high-grade non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy with cyclophosphamide etoposide and cisplatin followed by bone marrow andor peripheral stem cell transplantation in patients with relapsed or refractory intermediate- or high-grade non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the curative potential of high-dose cyclophosphamide etoposide and cisplatin CEP with syngeneic or autologous bone marrow andor autologous peripheral blood stem cell rescue in patients with relapsed or refractory stage I-IV intermediate- or high-grade non-Hodgkins lymphoma
Determine the overall response rate and survival of patients treated with this regimen
Determine the toxic effects of this regimen in these patients
Determine the differences in the rates of engraftment response and survival of patients treated with bone marrow vs peripheral blood stem cell transplantation
Determine the response rate and survival of patients treated with consolidative radiotherapy after recovery from transplantation
Determine the toxic effects of consolidative radiotherapy after recovery from transplantation in these patients
OUTLINE Syngeneic or autologous bone marrow andor autologous peripheral blood stem cells PBSC are harvested Syngeneic bone marrow transplantation is preferred for patients with a qualifying identical twin donor Patients without a syngeneic donor who have a history of lymphomatous involvement of the bone marrow and are profoundly hypocellular undergo harvest of PBSC alone Patients without a syngeneic donor who have no history of lymphomatous involvement of the bone marrow undergo harvest of autologous bone marrow or PBSC
Patients receive conditioning comprising cyclophosphamide IV over 1 hour on days -6 to -3 and etoposide IV over 1 hour every 12 hours and cisplatin IV continuously on days -6 to -4 Bone marrow andor PBSC are infused on day 0 Patients requiring more than 25 bags of stem cells receive bone marrow transplantation on day 0 and PBSC transplantation on day 1
After recovery from transplantation eligible patients receive consolidative radiotherapy to any site of prior bulk disease greater than 5 cm present at any time before transplantation and any site of disease present at the time of transplantation
Patients are followed at 3 6 and 12 months and then annually thereafter
PROJECTED ACCRUAL A maximum of 30 patients will be accrued for this study
Determine the curative potential of high-dose cyclophosphamide etoposide and cisplatin CEP with syngeneic or autologous bone marrow andor autologous peripheral blood stem cell rescue in patients with relapsed or refractory stage I-IV intermediate- or high-grade non-Hodgkins lymphoma
Determine the overall response rate and survival of patients treated with this regimen
Determine the toxic effects of this regimen in these patients
Determine the differences in the rates of engraftment response and survival of patients treated with bone marrow vs peripheral blood stem cell transplantation
Determine the response rate and survival of patients treated with consolidative radiotherapy after recovery from transplantation
Determine the toxic effects of consolidative radiotherapy after recovery from transplantation in these patients
OUTLINE Syngeneic or autologous bone marrow andor autologous peripheral blood stem cells PBSC are harvested Syngeneic bone marrow transplantation is preferred for patients with a qualifying identical twin donor Patients without a syngeneic donor who have a history of lymphomatous involvement of the bone marrow and are profoundly hypocellular undergo harvest of PBSC alone Patients without a syngeneic donor who have no history of lymphomatous involvement of the bone marrow undergo harvest of autologous bone marrow or PBSC
Patients receive conditioning comprising cyclophosphamide IV over 1 hour on days -6 to -3 and etoposide IV over 1 hour every 12 hours and cisplatin IV continuously on days -6 to -4 Bone marrow andor PBSC are infused on day 0 Patients requiring more than 25 bags of stem cells receive bone marrow transplantation on day 0 and PBSC transplantation on day 1
After recovery from transplantation eligible patients receive consolidative radiotherapy to any site of prior bulk disease greater than 5 cm present at any time before transplantation and any site of disease present at the time of transplantation
Patients are followed at 3 6 and 12 months and then annually thereafter
PROJECTED ACCRUAL A maximum of 30 patients 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-V93-0248 | None | None | None |
| TUHSC-2161 | None | None | None |