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
18 Years
N/A
Both
Breast Cancer, Kidney Cancer, Lung Cancer
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Henry Pan, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Neurocrine Biosciences
Authority:
United States: Federal Government
Study ID:
CDR0000069228
NCT ID:
NCT00039052
Start Date:
January 2002
Completion Date:
Related Keywords:
- Breast Cancer
- Kidney Cancer
- Lung Cancer
- 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
- Breast Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Carcinoma, Renal Cell
- Kidney Neoplasms
- Lung Neoplasms
Name | Location |
|---|---|
| Arizona Cancer Center | Tucson, Arizona 85724 |
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
