Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010192
Status:
COMPLETED
Last Update Posted:
2013-06-06
First Post:
2001-02-02
Brief Title:
Rituximab Plus Interleukin-2 in Treating Patients With Hematologic Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial Of Rituximab And Interleukin-2
Status:
COMPLETED
Status Verified Date:
2013-06
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:
Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Interleukin-2 may stimulate a persons white blood cells to kill cancer cells Combining rituximab with interleukin-2 may kill more cancer cells Phase I trial to study the effectiveness of rituximab plus interleukin-2 in treating patients who have hematologic cancer
Detailed Description:
OBJECTIVES Determine the dose-limiting toxicity of rituximab followed by low-dose and intermediate-dose pulse interleukin-2 IL-2 in patients with CD20-positive B-cell lymphoid malignancy
Determine the maximum tolerated dose of intermediate-dose pulse IL-2 in this patient population
Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is a dose-escalation study of intermediate-dose pulse aldesleukin
Patients receive rituximab IV on days 1 8 15 and 22 Patients then receive low-dose aldesleukin subcutaneously SC on days 29-39 43-53 57-67 and 71-81 and intermediate-dose aldesleukin SC on days 40-42 54-56 68-70 and 82-84 Cohorts of 3-6 patients receive escalating doses of intermediate-dose pulse aldesleukin until the maximum tolerated dose MTD is reached The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 3 months for 1 year
PROJECTED ACCRUAL A total of 3-30 patients will be accrued for this study within 1 year
Determine the maximum tolerated dose of intermediate-dose pulse IL-2 in this patient population
Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is a dose-escalation study of intermediate-dose pulse aldesleukin
Patients receive rituximab IV on days 1 8 15 and 22 Patients then receive low-dose aldesleukin subcutaneously SC on days 29-39 43-53 57-67 and 71-81 and intermediate-dose aldesleukin SC on days 40-42 54-56 68-70 and 82-84 Cohorts of 3-6 patients receive escalating doses of intermediate-dose pulse aldesleukin until the maximum tolerated dose MTD is reached The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 3 months for 1 year
PROJECTED ACCRUAL A total of 3-30 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| U01CA076576 | NIH | None | httpsreporternihgovquickSearchU01CA076576 |
| 0037 | None | None | None |
| CDR0000068454 | None | None | None |
| OSU-0037 | None | None | None |
| NCI-130 | None | None | None |
| OSU-00H0223 | None | None | None |