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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00039052
• Other study ID #: NBI-3001-ST-0101
• Secondary ID: CDR0000069228UAR
• Status: Completed
• Phase: Phase 1
• First received: June 6, 2002
• Last updated: July 17, 2013
• Start date: January 2002
• Est. completion date: July 2008

Study information

• Verified date: March 2003
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2008
• Est. primary completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms
• Lung Cancer
• Lung Neoplasms

Intervention

Biological:
• interleukin-4 PE38KDEL cytotoxin

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	Arizona Cancer Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Neurocrine Biosciences

Country where clinical trial is conducted

United States,