NCT00039052

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2002

Longer than P75 for phase_1 breast-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2002

Completed
8 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2003

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

July 18, 2013

Status Verified

March 1, 2003

Enrollment Period

1.3 years

First QC Date

June 6, 2002

Last Update Submit

July 17, 2013

Conditions

Breast CancerKidney CancerLung Cancer

Keywords

stage IV breast cancerrecurrent breast cancerrecurrent non-small cell lung cancerstage IV renal cell cancerrecurrent renal cell cancerstage IV non-small cell lung cancermale breast cancer

Interventions

interleukin-4 PE38KDEL cytotoxinBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-5907, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsKidney NeoplasmsLung NeoplasmsCarcinoma, Non-Small-Cell LungCarcinoma, Renal CellBreast Neoplasms, Male

Interventions

interleukin-4-Pseudomonas exotoxin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Henry Pan, MD, PhD

    Neurocrine Biosciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 6, 2002

First Posted

January 27, 2003

Study Start

January 1, 2002

Primary Completion

May 1, 2003

Study Completion

July 1, 2008

Last Updated

July 18, 2013

Record last verified: 2003-03

Locations

US(2)