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

NCT ID: NCT00039052

Last Updated: 2013-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31
• Study Completion Date: 2008-07-31

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.

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.

Conditions

Breast Cancer; Kidney Cancer; Lung Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

interleukin-4 PE38KDEL cytotoxin

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neurocrine Biosciences

INDUSTRY

Sponsor Role: lead

Principal Investigators

Henry Pan, MD, PhD

Role: STUDY_CHAIR

Neurocrine Biosciences

Locations

Arizona Cancer Center

Tucson, Arizona, United States

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, United States

Countries

United States

Other Identifiers

CDR0000069228

Identifier Type: REGISTRY

Identifier Source: secondary_id

UARIZ-HSC-01196

Identifier Type: -

Identifier Source: secondary_id

UCLA-0108085

Identifier Type: -

Identifier Source: secondary_id

NCI-V02-1692

Identifier Type: -

Identifier Source: secondary_id

NBI-3001-ST-0101

Identifier Type: -

Identifier Source: org_study_id