Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003451
Status:
COMPLETED
Last Update Posted:
2013-02-01
First Post:
1999-11-01
Brief Title:
Interleukin-12 Followed by Interferon Alfa in Treating Patients With Advanced Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Trial of Interleukin-12 Followed by Interferon-Alpha
Status:
COMPLETED
Status Verified Date:
2007-07
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:
Phase I trial to study the effectiveness of combining interleukin-12 and interferon alfa in treating patients who have residual recurrent or metastatic malignant melanoma or other advanced cancer that has not responded to standard therapy Interleukin-12 may stimulate a persons white blood cells to kill cancer cells Interferon alfa may interfere with the growth of the cancer cells Combining interleukin-12 with interferon alfa may kill more cancer cells
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose of interferon alfa when preceded by a single dose of interleukin-12 in patients with recurrent or metastatic melanoma or other advanced malignancies
OUTLINE This is a dose-escalation study
Cohorts of 3 patients receive interleukin-12 IV push on day 1 followed by escalating doses of interferon alfa by subcutaneous injection at 24 48 72 96 and 120 hours Courses repeat every 2 weeks for 6 months 12 courses total in the absence of unacceptable toxicity and disease progression Patients achieving partial response or stable disease at the completion of 6 months of therapy may receive additional courses of therapy for up to 24 months Dose escalation of interferon alfa continues in subsequent cohorts in the absence of dose limiting toxicity DLT If 1 of 3 patients experiences DLT at a dose level then 3 additional patients are entered at that dose level If 2 of 6 patients experience DLT then dose escalation stops The maximum tolerated dose is defined as 1 level below that dose at which 2 or more of 6 patients experience DLT Patients are followed every 3 months for 1 year and then every 6 months thereafter
I Determine the maximum tolerated dose of interferon alfa when preceded by a single dose of interleukin-12 in patients with recurrent or metastatic melanoma or other advanced malignancies
OUTLINE This is a dose-escalation study
Cohorts of 3 patients receive interleukin-12 IV push on day 1 followed by escalating doses of interferon alfa by subcutaneous injection at 24 48 72 96 and 120 hours Courses repeat every 2 weeks for 6 months 12 courses total in the absence of unacceptable toxicity and disease progression Patients achieving partial response or stable disease at the completion of 6 months of therapy may receive additional courses of therapy for up to 24 months Dose escalation of interferon alfa continues in subsequent cohorts in the absence of dose limiting toxicity DLT If 1 of 3 patients experiences DLT at a dose level then 3 additional patients are entered at that dose level If 2 of 6 patients experience DLT then dose escalation stops The maximum tolerated dose is defined as 1 level below that dose at which 2 or more of 6 patients experience DLT Patients are followed every 3 months for 1 year and then every 6 months thereafter
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 |
|---|---|---|---|
| OSU-T98-0020 | None | None | None |
| NCI-T98-0020 | None | None | None |
| CDR0000066482 | REGISTRY | PDQ Physician Data Query | None |