Intravenous Interleukin-4 PE38KDEL Cytotoxin in Treating Patients With Recurrent or Metastatic Kidney Cancer, Non-Small Cell Lung Cancer, or Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00039052
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 18, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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

Detailed Description:


  • 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)
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
Actual Primary Completion Date : May 2003
Actual Study Completion Date : July 2008

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed recurrent or unresponsive, metastatic renal cell, non-small cell lung, or breast cancer that has been treated previously with standard surgery, radiotherapy, chemotherapy, or immunotherapy or for which no available treatment options currently exist
  • Confirmed overexpression of interleukin-4 receptors
  • Measurable disease (lesions greater than 10 mm by CT scan) OR
  • Evaluable disease
  • No prior or concurrent clinically significant brain metastases
  • Hormone receptor status:

    • Not specified



  • 18 and over


  • Male or female

Menopausal status:

  • Not specified

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • More than 12 weeks


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • Transaminases no greater than 1.5 times ULN
  • Albumin at least 2.5 g/dL
  • Hepatitis B surface antigen negative
  • Hepatitis C antibody negative
  • No prior or concurrent hepatic disease (e.g., hepatitis or alcoholic liver disease)


  • Creatinine no greater than 2.0 mg/dL


  • See Surgery
  • Electrocardiogram normal
  • MUGA scan normal
  • No congestive heart failure
  • No cardiac arrhythmia requiring treatment
  • No myocardial infarction
  • No clinical evidence of coronary artery disease (unless there is a cardiac evaluation and evidence of adequate coronary function by a stress test or angiography)


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception for 4 weeks before, during, and for at least 3 months after study
  • No concurrent underlying medical condition that would preclude study or cannot be controlled
  • No active infection


Biologic therapy:

  • See Disease Characteristics


  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy:

  • Not specified


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy


  • See Disease Characteristics
  • At least 1 year since prior surgery or angioplasty for coronary artery disease


  • At least 28 days since prior experimental drugs and recovered

Information from the National Library of Medicine

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 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
Sponsors and Collaborators
Neurocrine Biosciences
Study Chair: Henry Pan, MD, PhD Neurocrine Biosciences Identifier: NCT00039052     History of Changes
Other Study ID Numbers: NBI-3001-ST-0101
CDR0000069228 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 18, 2013
Last Verified: March 2003

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer
recurrent non-small cell lung cancer
stage IV renal cell cancer
recurrent renal cell cancer
stage IV non-small cell lung cancer
male breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Kidney Neoplasms
Carcinoma, Renal Cell
Neoplasms by Site
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antirheumatic Agents