Breast Cancer, Kidney Cancer, Lung Cancer
Conditions
Keywords
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
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.
Interventions
BIOLOGICALinterleukin-4 PE38KDEL cytotoxin
Sponsors
Neurocrine Biosciences
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Countries
United States
Outcome results
None listed