Intravenous Interleukin-4 PE38KDEL Cytotoxin in Treating Patients With Recurrent or Metastatic Kidney Cancer, Non-Small Cell Lung Cancer, or Breast Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Kidney Cancer Lung Cancer |
Biological: interleukin-4 PE38KDEL cytotoxin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| 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 |
| Study Start Date: | January 2002 |
| Primary Completion Date: | May 2003 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Arizona | |
| Arizona Cancer Center | |
| Tucson, Arizona, United States, 85724 | |
| United States, California | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-5907 | |
| Study Chair: | Henry Pan, MD, PhD | Neurocrine Biosciences |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00039052 History of Changes |
| Other Study ID Numbers: | CDR0000069228, NBI-3001-ST-0101, UARIZ-HSC-01196, UCLA-0108085, NCI-V02-1692 |
| Study First Received: | June 6, 2002 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Breast Neoplasms Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Kidney Neoplasms Lung Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases |
Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Urologic Neoplasms Urogenital Neoplasms Kidney Diseases Urologic Diseases Interleukin-4 Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antirheumatic Agents Adjuvants, Immunologic Immunologic Factors |
ClinicalTrials.gov processed this record on May 16, 2013