Ignite Creation Date:
2024-05-05 @ 11:19 AM
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
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
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 |