Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028535
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2002-01-04
Brief Title:
Interleukin-12 Paclitaxel and Trastuzumab in Treating Patients With Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Trial of Interleukin-12 in Combination With Paclitaxel Plus Herceptin in Patients With Her2-positive Malignancies
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:
Phase I trial to study the effectiveness of interleukin-12 paclitaxel and trastuzumab in treating patients who have 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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Combining interleukin-12 chemotherapy and monoclonal antibody therapy may kill more tumor cells
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose of interleukin-12 when given in combination with paclitaxel and trastuzumab Herceptin in patients with HER2neu-overexpressing malignancies
II Determine the response rate and time to progression in patients treated with this regimen
III Determine the anti-tumor effect of this regimen in these patients
OUTLINE This is a dose-escalation study of interleukin-12
Patients receive trastuzumab Herceptin IV over 30-90 minutes on days 1 8 and 15 and paclitaxel IV over 3 hours on day 1 of course 1 Beginning with course 2 patients receive trastuzumab and paclitaxel as in course 1 and interleukin-12 subcutaneously on days 2 5 9 12 16 and 19 Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of interleukin-12 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 3 months for 1 year and then every 6 months thereafter
I Determine the maximum tolerated dose of interleukin-12 when given in combination with paclitaxel and trastuzumab Herceptin in patients with HER2neu-overexpressing malignancies
II Determine the response rate and time to progression in patients treated with this regimen
III Determine the anti-tumor effect of this regimen in these patients
OUTLINE This is a dose-escalation study of interleukin-12
Patients receive trastuzumab Herceptin IV over 30-90 minutes on days 1 8 and 15 and paclitaxel IV over 3 hours on day 1 of course 1 Beginning with course 2 patients receive trastuzumab and paclitaxel as in course 1 and interleukin-12 subcutaneously on days 2 5 9 12 16 and 19 Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of interleukin-12 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
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 |
|---|---|---|---|
| U01CA076576 | NIH | None | httpsreporternihgovquickSearchU01CA076576 |
| 1999C0326 | None | None | None |
| OSU-0167 | None | None | None |
| NCI-84 | None | None | None |
| OSU-99H0326 | None | None | None |
| CDR0000069102 | None | None | None |