Intravenous Interleukin-4 PE38KDEL Cytotoxin in Treating Patients With Recurrent or Metastatic Kidney Cancer, Non-Small Cell Lung Cancer, or Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00039052|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 18, 2013
RATIONALE: Interleukin-4 PE38KDEL cytotoxin may be able to deliver cancer-killing substances directly to solid tumor cells.
PURPOSE: Phase I trial to study the effectiveness of intravenous interleukin-4 PE38KDEL cytotoxin in treating patients who have recurrent or metastatic kidney cancer, non-small cell lung cancer, or breast cancer that has not responded to previous treatment.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Kidney Cancer Lung Cancer||Biological: interleukin-4 PE38KDEL cytotoxin||Phase 1|
- Determine the maximum tolerated dose of interleukin-4 PE38KDEL cytotoxin in patients with recurrent or unresponsive, metastatic renal cell, non-small cell lung, or breast cancer that overexpresses interleukin-4 receptors.
- Determine the qualitative and quantitative toxic effects of this drug, including the duration and intensity of these toxic effects, in these patients.
- Determine the pharmacokinetic behavior of this drug in these patients.
- Determine the antibody response (if any) in patients treated with this drug.
- Determine, in a preliminary manner, the antitumor activity of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive interleukin-4 PE38KDEL cytotoxin (NBI-3001) IV over 10 minutes once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression, unacceptable toxicity, or detection of neutralizing antibodies.
Cohorts of 3-6 patients receive escalating doses of NBI-3001 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A maximum of 36 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||An Open Label, Multiple-Dose, Sequential Dose-Escalation Study of NBI-3001 in Patients With Recurrent or Unresponsive Solid Tumors Known to Over-Express IL-4 Receptors|
|Study Start Date :||January 2002|
|Actual Primary Completion Date :||May 2003|
|Actual Study Completion Date :||July 2008|
U.S. FDA Resources
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00039052
|United States, Arizona|
|Arizona Cancer Center|
|Tucson, Arizona, United States, 85724|
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-5907|
|Study Chair:||Henry Pan, MD, PhD||Neurocrine Biosciences|