Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00110071
Status:
COMPLETED
Last Update Posted:
2014-08-06
First Post:
2005-05-03
Brief Title:
Iodine I 131 Tositumomab and Fludarabine Phosphate in Treating Older Patients Who Are Undergoing an Autologous or Syngeneic Stem Cell Transplant for Relapsed or Refractory Non-Hodgkins Lymphoma
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Clinical Trial Evaluating I131-Tositumomab Anti-CD20 With Escalating Doses of Fludarabine Followed by Autologous or Syngeneic Stem Cell Transplantation for Relapsed or Refractory B-cell Non-Hodgkins Lymphoma in Patients 60 Years of Age and Older
Status:
COMPLETED
Status Verified Date:
2014-08
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 I trial studies the side effects and best dose of fludarabine fludarabine phosphate when given together with iodine I 131 tositumomab in treating older patients who are undergoing an autologous or syngeneic stem cell transplant for relapsed or refractory B-cell non-Hodgkins lymphoma NHL Radiolabeled monoclonal antibodies such as iodine I 131 tositumomab can find cancer cells and carry cancer-killing substances to them without harming normal cells Drugs used in chemotherapy such as fludarabine work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy Giving iodine I 131 tositumomab together with fludarabine followed by autologous stem cell transplant may be an effective treatment for NHL
Detailed Description:
PRIMARY OBJECTIVES
I To estimate the maximally tolerated dose of fludarabine that can be combined with 131I-anti-CD20 iodine I 131 tositumomab delivering 27Gy to critical normal organs followed by autologous or syngeneic transplantation in patients 60 years of age with relapsed B-NHL
SECONDARY OBJECTIVES
I To assess the overall and progression-free survival of the above regimen in such patients
II To evaluate the response rates of the above therapy
III To evaluate the toxicity and tolerability of the above therapy
IV To evaluate the feasibility of delivering concurrent high-dose radioimmunotherapy RIT and chemotherapy
OUTLINE This is a dose-escalation study of fludarabine phosphate as used in combination with I 131 tositumomab and stem cell transplant
Patients receive a dosimetric dose of iodine I 131 tositumomab intravenously IV over 40-60 minutes on day -24 followed by gamma camera imaging over the next 6 days Patients then receive a therapeutic dose of iodine I 131 tositumomab via central line over 40-60 minutes on day -14 Patients also receive fludarabine phosphate IV once daily QD on days -11 to -9 OR days -11 or -7 Patients undergo autologous or syngeneic peripheral blood stem cell transplantation on day 0
Patients with circulating lymphoma cells by peripheral smear receive tositumomab IV over 1 hour OR rituximab IV over 1 hour followed by tositumomab IV over 1 hour before the dosimetric iodine I 131 tositumomab infusion
After completion of study treatment patients are followed up at 1 3 6 and 12 months and then annually thereafter
I To estimate the maximally tolerated dose of fludarabine that can be combined with 131I-anti-CD20 iodine I 131 tositumomab delivering 27Gy to critical normal organs followed by autologous or syngeneic transplantation in patients 60 years of age with relapsed B-NHL
SECONDARY OBJECTIVES
I To assess the overall and progression-free survival of the above regimen in such patients
II To evaluate the response rates of the above therapy
III To evaluate the toxicity and tolerability of the above therapy
IV To evaluate the feasibility of delivering concurrent high-dose radioimmunotherapy RIT and chemotherapy
OUTLINE This is a dose-escalation study of fludarabine phosphate as used in combination with I 131 tositumomab and stem cell transplant
Patients receive a dosimetric dose of iodine I 131 tositumomab intravenously IV over 40-60 minutes on day -24 followed by gamma camera imaging over the next 6 days Patients then receive a therapeutic dose of iodine I 131 tositumomab via central line over 40-60 minutes on day -14 Patients also receive fludarabine phosphate IV once daily QD on days -11 to -9 OR days -11 or -7 Patients undergo autologous or syngeneic peripheral blood stem cell transplantation on day 0
Patients with circulating lymphoma cells by peripheral smear receive tositumomab IV over 1 hour OR rituximab IV over 1 hour followed by tositumomab IV over 1 hour before the dosimetric iodine I 131 tositumomab infusion
After completion of study treatment patients are followed up 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 |
|---|---|---|---|
| P01CA044991 | NIH | CTRP Clinical Trial Reporting Program | httpsreporternihgovquickSearchP01CA044991 |
| NCI-2009-01470 | REGISTRY | None | None |