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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Kidney Cancer, Lung Cancer

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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 CenterTucson, Arizona  85724
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781