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

Sponsor:	Neurocrine Biosciences
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00039052

Purpose

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	Intervention	Phase
Breast Cancer Kidney Cancer Lung Cancer	Biological: interleukin-4 PE38KDEL cytotoxin	Phase I

Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Kidney Cancer Lung Cancer

Drug Information available for: Interleukin-4

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:	January 2002
Primary Completion Date:	May 2003 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Age:

18 and over

Sex:

Male or female

Menopausal status:

Not specified

Performance status:

Karnofsky 70-100%

Life expectancy:

More than 12 weeks

Hematopoietic:

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

Hepatic:

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)

Renal:

Creatinine no greater than 2.0 mg/dL

Cardiovascular:

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)

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

See Disease Characteristics

Chemotherapy:

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

Endocrine therapy:

Not specified

Radiotherapy:

See Disease Characteristics
At least 4 weeks since prior radiotherapy

Surgery:

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

Other:

At least 28 days since prior experimental drugs and recovered

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00039052

Locations

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

Investigators

Study Chair:

Henry Pan, MD, PhD

Neurocrine Biosciences

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000069228, NBI-3001-ST-0101, UARIZ-HSC-01196, UCLA-0108085, NCI-V02-1692
Study First Received:	June 6, 2002
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00039052 History of Changes
Health Authority:	United States: Federal Government

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:

Thoracic Neoplasms
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Urologic Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Urologic Diseases
Lung Neoplasms
Kidney Neoplasms
Therapeutic Uses
Kidney Diseases
Breast Diseases
Respiratory Tract Neoplasms

Neoplasms by Histologic Type
Skin Diseases
Adjuvants, Immunologic
Breast Neoplasms
Pharmacologic Actions
Carcinoma
Neoplasms
Lung Diseases
Interleukin-4
Carcinoma, Renal Cell
Antirheumatic Agents
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009