Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039052
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2002-06-06
Brief Title:
Intravenous Interleukin-4 PE38KDEL Cytotoxin in Treating Patients With Recurrent or Metastatic Kidney Cancer Non-Small Cell Lung Cancer or Breast Cancer
Sponsor:
Neurocrine Biosciences
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2003-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V02-1692 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000069228 | REGISTRY | None | None |
| UARIZ-HSC-01196 | None | None | None |
| UCLA-0108085 | None | None | None |