Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005858
Status:
COMPLETED
Last Update Posted:
2019-11-04
First Post:
2000-06-02
Brief Title:
LMB-9 Immunotoxin in Treating Patients With Advanced Colon Breast Non-small Cell Lung Bladder Pancreatic or Ovarian Cancer
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Phase I Study of LMB-9 a Recombinant Disulfide Stabilized Anti-Lewis Y Immunotoxin Admistered by Continuous Infusion
Status:
COMPLETED
Status Verified Date:
2019-10
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:
Phase I trial to study the effectiveness of LMB-9 immunotoxin in treating patients who have advanced colon breast non-small cell lung bladder pancreatic or ovarian cancer The LMB-9 immunotoxin can locate tumor cells and kill them without harming normal cells
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose of LMB-9 immunotoxin in patients with advanced colon breast non-small cell lung bladder pancreas or ovarian cancer
II Assess the toxicity and pharmacokinetics of this treatment regimen in these patients
III Determine the clinical responses in patients treated with this regimen
OUTLINE This is a dose-escalation study
Patients receive LMB-9 immunotoxin IV continuously for 10 days Treatment continues every 30 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of LMB-9 immunotoxin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed at 3 weeks and then every 2 months thereafter
I Determine the maximum tolerated dose of LMB-9 immunotoxin in patients with advanced colon breast non-small cell lung bladder pancreas or ovarian cancer
II Assess the toxicity and pharmacokinetics of this treatment regimen in these patients
III Determine the clinical responses in patients treated with this regimen
OUTLINE This is a dose-escalation study
Patients receive LMB-9 immunotoxin IV continuously for 10 days Treatment continues every 30 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of LMB-9 immunotoxin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed at 3 weeks and then every 2 months thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-511 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067885 | REGISTRY | None | None |
| MSGCC-IRB-0200123 | None | None | None |