Ignite Creation Date:
2024-05-05 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 9:52 AM
Study NCT ID:
NCT00720135
Status:
COMPLETED
Last Update Posted:
2015-06-08
First Post:
2008-07-19
Brief Title:
Fusion Protein Cytokine Therapy After Rituximab in Treating Patients With B-Cell Non-Hodgkin Lymphoma
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
A Phase I Study of De-Immunized DI-Leu16-IL2 Immunocytokine in Patients With B-Cell Non-Hodgkin Lymphoma
Status:
COMPLETED
Status Verified Date:
2015-06
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 Biological therapies such as fusion protein cytokine therapy may stimulate the immune system in different ways and stop cancer cells from growing 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 Giving fusion protein cytokine therapy together with rituximab may kill more cancer cells
PURPOSE This phase I trial is studying the side effects and best dose of fusion protein cytokine therapy when given after rituximab in treating patients with B-cell non-Hodgkin lymphoma
PURPOSE This phase I trial is studying the side effects and best dose of fusion protein cytokine therapy when given after rituximab in treating patients with B-cell non-Hodgkin lymphoma
Detailed Description:
PRIMARY OBJECTIVES
I To determine the maximum tolerated dose MTD of DI-Leu16-IL2 DI-Leu16-IL2 immunocytokine following peripheral blood B cell depletion with rituximab in patients with B-cell NHL
II To investigate the optimal biological dose OBD of DI-Leu16-IL2 following peripheral blood B cell depletion with rituximab in patients with B-cell NHL which may differ from the MTD
III To describe the toxicities associated with the proposed DI-Leu16-IL2 regimen
SECONDARY OBJECTIVES
I To evaluate the immunogenicity as measured by the induction of DI-Leu16-IL2-specific antibodies
II To evaluate the pharmacokinetics of DI-Leu16-IL2 III To document any clinical responses associated with the proposed therapy and survival endpoints of the enrolled patients
OUTLINE This is a dose-escalation study of DI-Leu16-IL2 immunocytokine
Patients receive DI-Leu16-IL2 immunocytokine IV over 4 hours on 4 consecutive Wednesdays
Patients with detectable CD20-positive B-cells pretreatment also receive rituximab IV on 4 consecutive Tuesdays
Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up periodically for 5 years
I To determine the maximum tolerated dose MTD of DI-Leu16-IL2 DI-Leu16-IL2 immunocytokine following peripheral blood B cell depletion with rituximab in patients with B-cell NHL
II To investigate the optimal biological dose OBD of DI-Leu16-IL2 following peripheral blood B cell depletion with rituximab in patients with B-cell NHL which may differ from the MTD
III To describe the toxicities associated with the proposed DI-Leu16-IL2 regimen
SECONDARY OBJECTIVES
I To evaluate the immunogenicity as measured by the induction of DI-Leu16-IL2-specific antibodies
II To evaluate the pharmacokinetics of DI-Leu16-IL2 III To document any clinical responses associated with the proposed therapy and survival endpoints of the enrolled patients
OUTLINE This is a dose-escalation study of DI-Leu16-IL2 immunocytokine
Patients receive DI-Leu16-IL2 immunocytokine IV over 4 hours on 4 consecutive Wednesdays
Patients with detectable CD20-positive B-cells pretreatment also receive rituximab IV on 4 consecutive Tuesdays
Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up periodically for 5 years
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 |
|---|---|---|---|
| P50CA107399 | NIH | PDQ | httpsreporternihgovquickSearchP50CA107399 |
| NCI-2010-01228 | None | None | None |
| CDR0000598679 | REGISTRY | None | None |