Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00073918
Status:
COMPLETED
Last Update Posted:
2017-08-18
First Post:
2003-12-10
Brief Title:
Iodine I 131 Tositumomab Etoposide and Cyclophosphamide Followed by Autologous Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkins Lymphoma
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Phase II Trial Evaluating The Efficacy of Radioiodinated Tositumomab Anti-CD20 Antibody Etoposide and Cyclophosphamide Followed by Autologous Transplantation for Relapsed or Refractory Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2017-07
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:
This phase II trial is studying how well giving iodine I 131 tositumomab together with etoposide and cyclophosphamide followed by autologous stem cell transplant works in treating patients with relapsed or refractory non-Hodgkins lymphoma Radiolabeled monoclonal antibodies such as iodine I 131 tositumomab can find cancer cells and deliver radioactive cancer-killing substances to them without harming normal cells Drugs used in chemotherapy such as etoposide and cyclophosphamide work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Combining a radiolabeled monoclonal antibody with combination chemotherapy before autologous stem cell transplant may kill more cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I To assess the progression-free survival of patients receiving 131 I labeled tositumomab antibody etoposide VP-16 and cyclophosphamide CY followed by autologous transplantation
II To examine the potential efficacy of 131 I labeled tositumomab antibody etoposide VP-16 and cyclophosphamide CY followed by autologous transplantation
SECONDARY OBJECTIVES
I To assess the overall survival of patients receiving 131 I labeled tositumomab antibody etoposide VP-16 and cyclophosphamide CY followed by autologous transplantation
II To evaluate the toxicity and tolerability of the above therapy
OUTLINE
RADIOIMMUNOTHERAPY Patients receive a test dose of iodine I 131 tositumomab intravenously IV on day -24 to determine biodistribution Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4
CHEMOTHERAPY Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2
AUTOLOGOUS STEM CELL TRANSPLANTATION Patients undergo autologous peripheral blood stem cell transplant on day 0
After completion of study treatment patients are followed at 1 3 6 and 12 months and then annually thereafter
I To assess the progression-free survival of patients receiving 131 I labeled tositumomab antibody etoposide VP-16 and cyclophosphamide CY followed by autologous transplantation
II To examine the potential efficacy of 131 I labeled tositumomab antibody etoposide VP-16 and cyclophosphamide CY followed by autologous transplantation
SECONDARY OBJECTIVES
I To assess the overall survival of patients receiving 131 I labeled tositumomab antibody etoposide VP-16 and cyclophosphamide CY followed by autologous transplantation
II To evaluate the toxicity and tolerability of the above therapy
OUTLINE
RADIOIMMUNOTHERAPY Patients receive a test dose of iodine I 131 tositumomab intravenously IV on day -24 to determine biodistribution Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4
CHEMOTHERAPY Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2
AUTOLOGOUS STEM CELL TRANSPLANTATION Patients undergo autologous peripheral blood stem cell transplant on day 0
After completion of study treatment patients are followed at 1 3 6 and 12 months and then annually thereafter
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-2009-01469 | REGISTRY | None | None |
| P01CA044991 | NIH | CTRP Clinical Trial Reporting Program | httpsreporternihgovquickSearchP01CA044991 |