Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017381
Status:
COMPLETED
Last Update Posted:
2013-01-09
First Post:
2001-06-06
Brief Title:
Monoclonal Antibody Therapy and Peripheral Stem Cell Transplant in Treating Patients With Non-Hodgkins Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Dose Finding Study of IDEC-Y2B8 With Autologous Stem Cell Support
Status:
COMPLETED
Status Verified Date:
2013-01
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:
This phase I trial is studying how well monoclonal antibody therapy with peripheral stem cell transplant works in treating patients with non-Hodgkins lymphoma Monoclonal antibodies such as rituximab can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or carry cancer-killing substances to them Peripheral stem cell transplant may allow the doctor to give higher doses of monoclonal antibodies and kill more cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I To determine the maximum tolerated dose of IDEC-Y2B8 when administered with rituximab in vivo purging and autologous stem cell rescue
II To obtain correlative laboratory data of in vivo purging with rituximab in patients with 0-35 marrow involvement
OUTLINE This is a multicenter dose-escalation study of yttrium Y 90 ibritumomab tiuxetan IDEC-Y2B8
PART I Patients receive rituximab IV on days 1 8 15 and 22 and cyclophosphamide IV over 1 hour on day 25 Filgrastim G-CSF is administered subcutaneously SC daily beginning on day 26 and continuing until autologous peripheral blood stem cells PBSC are harvested
PART II Beginning 4-6 weeks after completion of the fourth rituximab infusion patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1 followed by dosimetry imaging on days 1 2 4 and 7 Patients then receive IDEC-Y2B8 IV over 10 minutes once between days 8-15
The initial 3 patients receive the same dose of IDEC-Y2B8 and then subsequent cohorts of 3-5 patients receive escalating doses of IDEC-Y2B8 until the maximum tolerated dose is determined
PART III All patients undergo PBSC transplantation PBSCT beginning after residual bone marrow radioactivity resolves G-CSF is administered SC beginning 1 day after PBSCT and continuing until blood counts recover
Patients are followed every 3 months for 1 year and then every 6 months thereafter
I To determine the maximum tolerated dose of IDEC-Y2B8 when administered with rituximab in vivo purging and autologous stem cell rescue
II To obtain correlative laboratory data of in vivo purging with rituximab in patients with 0-35 marrow involvement
OUTLINE This is a multicenter dose-escalation study of yttrium Y 90 ibritumomab tiuxetan IDEC-Y2B8
PART I Patients receive rituximab IV on days 1 8 15 and 22 and cyclophosphamide IV over 1 hour on day 25 Filgrastim G-CSF is administered subcutaneously SC daily beginning on day 26 and continuing until autologous peripheral blood stem cells PBSC are harvested
PART II Beginning 4-6 weeks after completion of the fourth rituximab infusion patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1 followed by dosimetry imaging on days 1 2 4 and 7 Patients then receive IDEC-Y2B8 IV over 10 minutes once between days 8-15
The initial 3 patients receive the same dose of IDEC-Y2B8 and then subsequent cohorts of 3-5 patients receive escalating doses of IDEC-Y2B8 until the maximum tolerated dose is determined
PART III All patients undergo PBSC transplantation PBSCT beginning after residual bone marrow radioactivity resolves G-CSF is administered SC beginning 1 day after PBSCT and continuing until blood counts recover
Patients are followed every 3 months for 1 year and then every 6 months 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 |
|---|---|---|---|
| J0004 | None | None | None |