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1999-08
2009-02
N/A
15
NCT00004074
National Cancer Institute (NCI)
National Cancer Institute (NCI)
INTERVENTIONAL
Interleukin-12 and Trastuzumab in Treating Patients With Cancer That Has High Levels of HER2/Neu
Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's 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 HER2/neu and has not responded to previous therapy
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
1999-12-10 | N/A | 2013-02-27 |
2003-10-28 | N/A | 2013-02-28 |
2003-10-29 | N/A | 2013-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Treatment (IL12 and trastuzumab) 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 | BIOLOGICAL: recombinant interleukin-12
BIOLOGICAL: ABI-007/carboplatin/trastuzumab
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 2.0 (CTCAE v2.0) | Up to 52 weeks |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
