Breast Cancer 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
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.
OBJECTIVES:
- 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.
;
Primary Purpose: Treatment
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