Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004260
Status:
COMPLETED
Last Update Posted:
2011-08-03
First Post:
2000-01-28
Brief Title:
Interleukin-12 Plus Rituximab in Treating Patients With Non-Hodgkins Lymphoma
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Phase I Study of Interleukin-12 in Combination With Rituximab in Patients With Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2011-08
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:
RATIONALE Interleukin-12 may stimulate a persons white blood cells to kill lymphoma cells Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells
PURPOSE Phase I trial to study the effectiveness of interleukin-12 plus rituximab in treating patients who have non-Hodgkins lymphoma
PURPOSE Phase I trial to study the effectiveness of interleukin-12 plus rituximab in treating patients who have non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Determine the optimal immunological dose of interleukin-12 and rituximab when administered in combination in patients with non-Hodgkins lymphoma II Determine the toxicities associated with this regimen in this patient population III Assess the pharmacodynamics of this regimen in these patients IV Document observed clinical response to this regimen in these patients
OUTLINE This is a dose escalation study of interleukin-12 Patients receive rituximab IV on days 1 8 15 and 22 The first cohort of patients receives interleukin-12 SC twice weekly beginning on day 29 Subsequent cohorts receive interleukin-12 SC twice weekly beginning on day 16 Patients with stable or responding disease may continue treatment with interleukin-12 twice weekly for up to 24 weeks or until disease progression Cohorts of 6-9 patients receive escalating doses of interleukin-12 until the optimal immunological dose is determined The optimal immunological dose is defined as the dose preceding that at which 2 of 6 or 2 of 9 patients experience dose limiting toxicities or the dose at which there is a maximal increase in gamma interferon inducible protein-10 IP-10 and immune cell infiltration into the lymphoma whichever dose is lower Following initial dose escalation 2 additional cohorts of 6 patients receive a fixed dose of interleukin-12 SC twice weekly beginning on day 2 Patients are followed every 3 months for the first year and then every 6 months for the next 4 years or until disease progression
PROJECTED ACCRUAL A maximum of 45 patients will be accrued for this study within 12-13 months
OUTLINE This is a dose escalation study of interleukin-12 Patients receive rituximab IV on days 1 8 15 and 22 The first cohort of patients receives interleukin-12 SC twice weekly beginning on day 29 Subsequent cohorts receive interleukin-12 SC twice weekly beginning on day 16 Patients with stable or responding disease may continue treatment with interleukin-12 twice weekly for up to 24 weeks or until disease progression Cohorts of 6-9 patients receive escalating doses of interleukin-12 until the optimal immunological dose is determined The optimal immunological dose is defined as the dose preceding that at which 2 of 6 or 2 of 9 patients experience dose limiting toxicities or the dose at which there is a maximal increase in gamma interferon inducible protein-10 IP-10 and immune cell infiltration into the lymphoma whichever dose is lower Following initial dose escalation 2 additional cohorts of 6 patients receive a fixed dose of interleukin-12 SC twice weekly beginning on day 2 Patients are followed every 3 months for the first year and then every 6 months for the next 4 years or until disease progression
PROJECTED ACCRUAL A maximum of 45 patients will be accrued for this study within 12-13 months
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 |
|---|---|---|---|
| 980112 | OTHER | Mayo Clinic Cancer Center | httpsreporternihgovquickSearchU01CA069912 |
| U01CA069912 | NIH | None | None |