Viewing Study NCT00006981



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Last Modification Date: 2024-10-26 @ 9:05 AM
Study NCT ID: NCT00006981
Status: COMPLETED
Last Update Posted: 2015-04-30
First Post: 2000-12-06

Brief Title: Immunotoxin Therapy in Treating Patients With Advanced Cancer
Sponsor: National Cancer Institute NCI
Organization: National Cancer Institute NCI

Study Overview

Official Title: Phase I Study Of SS1dsFv-PE38 SS1P Anti-Mesothelin Immunotoxin in Advanced Malignancies Continuous Infusion X 10 Days
Status: COMPLETED
Status Verified Date: 2005-05
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 Immunotoxins can locate tumor cells and kill them without harming normal cells Immunotoxin therapy may be an effective treatment for advanced cancer

PURPOSE Phase I trial to study the effectiveness of immunotoxins in treating patients who have advanced cancer
Detailed Description: OBJECTIVES

Primary

Determine the maximum tolerated dose and toxic effects of SS1dsFv-PE38 immunotoxin in patients with advanced malignancies that express mesothelin

Secondary

Determine the response in patients treated with this drug
Determine the plasma pharmacokinetics of this drug in these patients

OUTLINE This is an open-label dose-escalation study

Patients receive SS1dsFv-PE38 immunotoxin IV continuously on days 1-10 Treatment repeats every 4 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity

Cohorts of 3-6 patients receive escalating doses of SS1dsFv-PE38 immunotoxin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity

Patients are followed every 3 months

PROJECTED ACCRUAL A total of 30 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-6249 None None None
NCI-01-C-0011 None None None