Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040950
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2002-07-08
Brief Title:
Biological Therapy Plus Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkins Lymphoma
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Multi-Center Phase I Open Label Two Arm Non-Randomized Dose-Escalation Study Of The Safety And Tolerability Of CPG 7909 In Patients Receiving Rituxan For Relapsed Or Refractory B-Cell Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2003-07
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:
RATIONALE Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Biological therapies such as CpG 7909 use different ways to stimulate the immune system and stop cancer cells from growing Combining CpG 7909 with rituximab may kill more cancer cells
PURPOSE Phase I trial to study the effectiveness of CpG 7909 plus rituximab in treating patients who have relapsed or refractory non-Hodgkins lymphoma
PURPOSE Phase I trial to study the effectiveness of CpG 7909 plus rituximab in treating patients who have relapsed or refractory non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of subcutaneous and IV CpG 7909 when administered with rituximab in patients with relapsed or refractory B-cell non-Hodgkins lymphoma
Determine the safety and tolerability of this regimen in these patients
Determine the disease response in patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of CpG 7909 Patients are sequentially assigned to 1 of 2 treatment groups
Group A Patients receive rituximab IV over 4-5 hours followed by CpG 7909 IV over 2 hours on day 1 Courses repeat weekly for 4 weeks
Group B Patients receive rituximab as above followed by CpG 7909 subcutaneously on day 1 Courses repeat weekly for 4 weeks
Cohorts of 3-6 patients receive escalating doses of CpG 7909 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed at 4 weeks
PROJECTED ACCRUAL A total of 6-48 patients 3-24 per treatment group will be accrued for this study
Determine the maximum tolerated dose of subcutaneous and IV CpG 7909 when administered with rituximab in patients with relapsed or refractory B-cell non-Hodgkins lymphoma
Determine the safety and tolerability of this regimen in these patients
Determine the disease response in patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of CpG 7909 Patients are sequentially assigned to 1 of 2 treatment groups
Group A Patients receive rituximab IV over 4-5 hours followed by CpG 7909 IV over 2 hours on day 1 Courses repeat weekly for 4 weeks
Group B Patients receive rituximab as above followed by CpG 7909 subcutaneously on day 1 Courses repeat weekly for 4 weeks
Cohorts of 3-6 patients receive escalating doses of CpG 7909 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed at 4 weeks
PROJECTED ACCRUAL A total of 6-48 patients 3-24 per treatment group will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G02-2086 | None | None | None |
| UCLA-0112032 | None | None | None |
| CPGI-C004-CPG7909 | None | None | None |