Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004074
Status:
COMPLETED
Last Update Posted:
2013-02-28
First Post:
1999-12-10
Brief Title:
Interleukin-12 and Trastuzumab in Treating Patients With Cancer That Has High Levels of HER2Neu
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial of Herceptin and Interleukin-12
Status:
COMPLETED
Status Verified Date:
2013-02
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:
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 Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Phase I trial to study the effectiveness of interleukin-12 and trastuzumab in treating patients who have cancer that has high levels of HER2neu and has not responded to previous therapy
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose of interleukin-12 IL-12 when combined with trastuzumab in patients with HER2-Neu overexpressing malignancies
II Determine the safety of this regimen in these patients
III Analyze any expression of interferon-inducible genes in tumor tissues of these patients after receiving this regimen
IV Characterize natural killer cytokine production in patients treated with this regimen
V Determine serum interferon gamma levels in patients treated with this regimen
OUTLINE
This is a dose escalation study of interleukin-12 IL-12
Patients receive an initial loading dose of trastuzumab IV over 90 minutes on day 1 of the first week and a maintenance dose of trastuzumab IV over 30-90 minutes on day 1 of each subsequent week Patients receive IL-12 IV on days 2 and 5 beginning on week 3 Treatment with maintenance trastuzumab and IL-12 repeats weekly for 14 weeks in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease continue treatment for up to 38 additional weeks
Cohorts of 3-6 patients receive escalating doses of IL-12 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 every 3 months for 1 year and then every 6 months thereafter for survival
PROJECTED ACCRUAL A total of 15 patients will be accrued for this study within 6 months
I Determine the maximum tolerated dose of interleukin-12 IL-12 when combined with trastuzumab in patients with HER2-Neu overexpressing malignancies
II Determine the safety of this regimen in these patients
III Analyze any expression of interferon-inducible genes in tumor tissues of these patients after receiving this regimen
IV Characterize natural killer cytokine production in patients treated with this regimen
V Determine serum interferon gamma levels in patients treated with this regimen
OUTLINE
This is a dose escalation study of interleukin-12 IL-12
Patients receive an initial loading dose of trastuzumab IV over 90 minutes on day 1 of the first week and a maintenance dose of trastuzumab IV over 30-90 minutes on day 1 of each subsequent week Patients receive IL-12 IV on days 2 and 5 beginning on week 3 Treatment with maintenance trastuzumab and IL-12 repeats weekly for 14 weeks in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease continue treatment for up to 38 additional weeks
Cohorts of 3-6 patients receive escalating doses of IL-12 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 every 3 months for 1 year and then every 6 months thereafter for survival
PROJECTED ACCRUAL A total of 15 patients will be accrued for this study within 6 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 |
|---|---|---|---|
| CDR0000067282 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA076576 |
| 99H0185 | None | None | None |
| U01CA076576 | NIH | None | None |