Breast CancerPhase 1NCT00039052
Intravenous Interleukin-4 PE38KDEL Cytotoxin in Treating Patients With Recurrent or Metastatic Kidney Cancer, Non-Small Cell Lung Cancer, or Breast Cancer
A Phase 1 study testing interleukin-4 PE38KDEL cytotoxin in people with Breast Cancer and Kidney Cancer, run by Neurocrine Biosciences at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Kidney Cancer, Lung Cancer
- What is being tested?
- interleukin-4 PE38KDEL cytotoxin
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Jan 2002to Jul 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-5907
Arizona Cancer Center
Tucson, Arizona, 85724
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer, Kidney Cancer, Lung Cancer
- Being tested
- interleukin-4 PE38KDEL cytotoxin
- 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
- Medical subject headings
- Breast Neoplasms, Kidney Neoplasms, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interleukin-4 PE38KDEL cytotoxinBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJan 2002
- Primary completionMay 2003
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Neurocrine BiosciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Neurocrine Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Henry Pan, MD, PhD, Study chair, Neurocrine Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00039052
- Sponsor's protocol ID
- NBI-3001-ST-0101
- Other IDs
- CDR0000069228, UARIZ-HSC-01196, UCLA-0108085, NCI-V02-1692
- Status last verified
- Mar 2003
- First submitted
- 6 Jun 2002
- Last updated
- 18 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00039052
- Acronym / sponsor ID
- NBI-3001-ST-0101
- Conditions
- Breast Cancer, Kidney Cancer, Lung Cancer
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Neurocrine BiosciencesIndustry (pharma, biotech, devices)
- Study start
- Jan 2002
- Primary completion
- May 2003 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interleukin-4 PE38KDEL cytotoxin | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry Pan, MD, PhD study chair
Neurocrine Biosciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing interleukin-4 PE38KDEL cytotoxin in people with Breast Cancer and Kidney Cancer, run by Neurocrine Biosciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2013.