Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010270
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
2001-02-02
Brief Title:
LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic Esophageal Stomach Colon or Rectal Cancer
Sponsor:
University Hospital Freiburg
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study Of LMB-9 A Recombinant Disulfide Stabilized Anti-Lewis Y Immonutoxin Administered By 5-Days Continuous Infusion For Patients With Colorectal Adenocarcinoma
Status:
UNKNOWN
Status Verified Date:
2007-01
Last Known Status:
ACTIVE_NOT_RECRUITING
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 LMB-9 immunotoxin can locate tumor cells and kill them without harming normal cells This may be an effective treatment for advanced pancreatic esophageal stomach colon or rectal cancer
PURPOSE Phase I trial to study the effectiveness of LMB-9 immunotoxin in treating patients who have advanced pancreatic esophageal stomach colon or rectal cancer
PURPOSE Phase I trial to study the effectiveness of LMB-9 immunotoxin in treating patients who have advanced pancreatic esophageal stomach colon or rectal cancer
Detailed Description:
OBJECTIVES
Determine the toxicity of LMB-9 immunotoxin in patients with advanced adenocarcinoma of the colon rectum pancreas esophagus or stomach with overexpression of the Lewis-Y antigen
Determine the maximum tolerated dose of this drug in these patients
Determine the clinical response of patients treated with this drug
Determine the pharmacokinetics of this drug in these patients
OUTLINE This is a dose-escalation study
Patients receive LMB-9 immunotoxin IV continuously on days 1-5 Patients with stable or responding disease after completion of the first course receive additional courses every 4-5 weeks 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 at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed at 3 weeks and then every 2 months thereafter
PROJECTED ACCRUAL A total of 40-50 patients will be accrued for this study within 1-2 years
Determine the toxicity of LMB-9 immunotoxin in patients with advanced adenocarcinoma of the colon rectum pancreas esophagus or stomach with overexpression of the Lewis-Y antigen
Determine the maximum tolerated dose of this drug in these patients
Determine the clinical response of patients treated with this drug
Determine the pharmacokinetics of this drug in these patients
OUTLINE This is a dose-escalation study
Patients receive LMB-9 immunotoxin IV continuously on days 1-5 Patients with stable or responding disease after completion of the first course receive additional courses every 4-5 weeks 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 at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed at 3 weeks and then every 2 months thereafter
PROJECTED ACCRUAL A total of 40-50 patients will be accrued for this study within 1-2 years
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 |
|---|---|---|---|
| EU-20120 | None | None | None |
| UFMC-431 | None | None | None |
| UFMC-IND-7697 | None | None | None |
| UFMC-NSC-691236 | None | None | None |
| NCI-431 | None | None | None |