Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003957
Status:
COMPLETED
Last Update Posted:
2013-04-17
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Non-Hodgkins Lymphoma
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
A Phase II Trial of Multiple Cycles of Sequential High Dose Chemotherapy for Patients With Chemotherapy Sensitive Relapsed Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2013-04
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 cancer cells from dividing so they stop growing or die Combining chemotherapy with autologous peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have relapsed non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have relapsed non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Determine how many patients with chemotherapy sensitive relapsed non-Hodgkins lymphoma receiving sequential high dose chemotherapy achieve a collection of a minimum 5 million CD34 cellskg in one large volume apheresis II Determine the feasibility and safety of this regimen in these patients III Determine disease free and overall survival of patients receiving this regimen
OUTLINE Patients receive cyclophosphamide IV over 1 hour followed by paclitaxel IV over 24 hours on day 1 Filgrastim G-CSF and stem cell factor SCF are administered subcutaneously beginning on day 3 for approximately 7-14 days until the completion of leukapheresis Peripheral blood stem cells PBSC are collected over 3-5 days Three weeks after leukapheresis is completed patients receive cytarabine IV over 2 hours twice a day on days -6 to -3 Mitoxantrone IV is administered over 1 hour on day -6 CD34 PBSC are reinfused on day 0 Four weeks later patients receive etoposide IV over 11 hours on day -2 and melphalan IV over 30 minutes twice on day -1 CD34 PBSC are reinfused on day 0 Concurrent G-CSF is administered subcutaneously and continues until blood counts recover Patients are followed at 4 weeks every 3 months for the first 2 years and then every 6 months for the next 2 years
PROJECTED ACCRUAL A total of 12 patients will be accrued for this study
OUTLINE Patients receive cyclophosphamide IV over 1 hour followed by paclitaxel IV over 24 hours on day 1 Filgrastim G-CSF and stem cell factor SCF are administered subcutaneously beginning on day 3 for approximately 7-14 days until the completion of leukapheresis Peripheral blood stem cells PBSC are collected over 3-5 days Three weeks after leukapheresis is completed patients receive cytarabine IV over 2 hours twice a day on days -6 to -3 Mitoxantrone IV is administered over 1 hour on day -6 CD34 PBSC are reinfused on day 0 Four weeks later patients receive etoposide IV over 11 hours on day -2 and melphalan IV over 30 minutes twice on day -1 CD34 PBSC are reinfused on day 0 Concurrent G-CSF is administered subcutaneously and continues until blood counts recover Patients are followed at 4 weeks every 3 months for the first 2 years and then every 6 months for the next 2 years
PROJECTED ACCRUAL A total of 12 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 |
|---|---|---|---|
| FCCC-98052 | None | None | None |
| NCI-G99-1541 | None | None | None |