Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005604
Status:
COMPLETED
Last Update Posted:
2013-02-01
First Post:
2000-05-02
Brief Title:
Interleukin-12 Plus Interleukin-2 in Treating Patients With Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Trial of Twice Weekly IV IL-12 Plus Low-Dose Subcutaneous IL-2 in Patients With Advanced Malignancies
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:
Phase I trial to study the effectiveness of interleukin-12 plus interleukin-2 in treating patients who have advanced solid tumors Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a persons white blood cells to kill cancer cells Interleukin-2 may stimulate a persons white blood cells to kill cancer cells Combining the two drugs may kill more cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I To determine the toxicity profile and MTD of low-dose SC IL-2 administered in conjunction with BIW regimen of IV rhIL-12
II To determine the antitumor effects of combination therapy with IV rhIL-12 and SC IL-2
III To determine the impact low-dose SC IL-2 has on the magnitude and duration of in vivo immune activation induced by a BIW schedule of IV rhIL-12
OUTLINE This is a dose-escalation study
Patients receive interleukin-12 IL-12 IV on days 1 and 4 for 6 weeks Beginning on day 4 of the third week patients receive interleukin-2 IL-2 subcutaneously 1 hour before and 20 hours after each dose of IL-12 On subsequent courses IL-2 and IL-12 are administered on days 1 and 4 of each week Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity Patients with disease response may continue treatment until complete response or disease progression
Cohorts of 3-6 patients receive escalating doses of IL-12 and IL-2 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
Patients are followed at 3 weeks
I To determine the toxicity profile and MTD of low-dose SC IL-2 administered in conjunction with BIW regimen of IV rhIL-12
II To determine the antitumor effects of combination therapy with IV rhIL-12 and SC IL-2
III To determine the impact low-dose SC IL-2 has on the magnitude and duration of in vivo immune activation induced by a BIW schedule of IV rhIL-12
OUTLINE This is a dose-escalation study
Patients receive interleukin-12 IL-12 IV on days 1 and 4 for 6 weeks Beginning on day 4 of the third week patients receive interleukin-2 IL-2 subcutaneously 1 hour before and 20 hours after each dose of IL-12 On subsequent courses IL-2 and IL-12 are administered on days 1 and 4 of each week Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity Patients with disease response may continue treatment until complete response or disease progression
Cohorts of 3-6 patients receive escalating doses of IL-12 and IL-2 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
Patients are followed at 3 weeks
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 |
|---|---|---|---|
| CDR0000067723 | REGISTRY | PDQ Physician Data Query | None |
| BIDMC 99-1332 | None | None | None |