Intravenous Interleukin-4 PE38KDEL Cytotoxin in Treating Patients With Recurrent or Metastatic Kidney Cancer, Non-Small Cell Lung Cancer, or Breast Cancer
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.
Biological: interleukin-4 PE38KDEL cytotoxin
|Study Design:||Primary Purpose: Treatment|
|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|
|Primary Completion Date:||May 2003 (Final data collection date for primary outcome measure)|
- 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.
|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|