Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003330
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
1999-11-01
Brief Title:
Interleukin-12 in Treating Patients With Advanced Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Clinical Trials of IV rhIL-12 With or Without a Test-Dose in Patients With Advanced Malignancies rhIL-12 NSC 672423
Status:
COMPLETED
Status Verified Date:
2001-05
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 in treating patients who have advanced cancer 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
Detailed Description:
OBJECTIVES
I Determine the toxicity profile and maximum tolerated dose MTD of intravenous interleukin-12 IL-12 administered biweekly for 6-18 weeks in the presence and absence of a test dose in patients with metastatic or unresectable malignancies
II Determine the optimal timing for administration of an IL-12 test dose based on its impact on secondary biologic parameters in these patients
III Determine the antitumor effects of IL-12 administered according to this schedule with and without a test dose in these patients
IV Determine the effect of a test dose on toxicity profile MTD tumor response and various biologic phenomena in serum and where possible tumor and liver in these patients
OUTLINE This is a 3-part dose escalation study
In Part A patients receive intravenous interleukin-12 IL-12 twice a week for 6 weeks Courses are repeated until patients achieve a complete response or there is disease progression Dose escalation of IL-12 continues in cohorts of 3-6 patients until the maximum tolerated dose MTD is determined The MTD is defined as the dose below that at which 2 of 6 patients experience dose limiting toxicity DLT
In Part B patients receive a single test dose of IL-12 administered intravenously at a 1 2 or 3 week interval prior to starting the multidose twice a week regimen as in Part A Cohorts of 4 patients will receive IL-12 at the MTD obtained in Part A
In Part C patients receive IL-12 at one dose level above the MTD obtained in Part A using the optimal schedule for the test dose determined in Part B Dose escalation continues in cohorts of 3-6 patients until the MTD is determined The MTD is defined as the dose below that at which 2 of 6 patients experience DLT Patients may continue to receive IL-12 until they have no measurable disease or until disease progression
I Determine the toxicity profile and maximum tolerated dose MTD of intravenous interleukin-12 IL-12 administered biweekly for 6-18 weeks in the presence and absence of a test dose in patients with metastatic or unresectable malignancies
II Determine the optimal timing for administration of an IL-12 test dose based on its impact on secondary biologic parameters in these patients
III Determine the antitumor effects of IL-12 administered according to this schedule with and without a test dose in these patients
IV Determine the effect of a test dose on toxicity profile MTD tumor response and various biologic phenomena in serum and where possible tumor and liver in these patients
OUTLINE This is a 3-part dose escalation study
In Part A patients receive intravenous interleukin-12 IL-12 twice a week for 6 weeks Courses are repeated until patients achieve a complete response or there is disease progression Dose escalation of IL-12 continues in cohorts of 3-6 patients until the maximum tolerated dose MTD is determined The MTD is defined as the dose below that at which 2 of 6 patients experience dose limiting toxicity DLT
In Part B patients receive a single test dose of IL-12 administered intravenously at a 1 2 or 3 week interval prior to starting the multidose twice a week regimen as in Part A Cohorts of 4 patients will receive IL-12 at the MTD obtained in Part A
In Part C patients receive IL-12 at one dose level above the MTD obtained in Part A using the optimal schedule for the test dose determined in Part B Dose escalation continues in cohorts of 3-6 patients until the MTD is determined The MTD is defined as the dose below that at which 2 of 6 patients experience DLT Patients may continue to receive IL-12 until they have no measurable disease or until disease progression
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 |
|---|---|---|---|
| NCI-T97-0053 | None | None | None |
| BIH-97-1083 | None | None | None |