Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066651
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2003-08-06
Brief Title:
Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study Of SS1dsFv-PE38 Anti-Mesothelin Immunotoxin In Advanced Malignancies IV Infusion QOD Dosing
Status:
COMPLETED
Status Verified Date:
2006-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 effective in treating advanced solid tumors
PURPOSE This phase I trial is studying the side effects and best dose of immunotoxin therapy in treating patients with recurrent unresectable advanced solid tumors
PURPOSE This phase I trial is studying the side effects and best dose of immunotoxin therapy in treating patients with recurrent unresectable advanced solid tumors
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of SS1dsFv-PE38 immunotoxin in patients with advanced mesothelin-expressing malignancies
Secondary
Determine the toxic effects of this drug in these patients
Determine the plasma pharmacokinetics of this drug in these patients
Determine the response in patients treated with this drug
Correlate the induction of antibody against this drug with its pharmacokinetics in these patients
OUTLINE This is an open-label dose-escalation study
Patients receive a test dose of SS1dsFv-PE38 immunotoxin IV over 1-2 minutes on day 1 followed by SS1dsFv-PE38 immunotoxin IV over 30 minutes on days 1 3 and 5 Treatment repeats every 4 weeks for up to 3 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 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 3-15 patients will be accrued for this study
Primary
Determine the maximum tolerated dose of SS1dsFv-PE38 immunotoxin in patients with advanced mesothelin-expressing malignancies
Secondary
Determine the toxic effects of this drug in these patients
Determine the plasma pharmacokinetics of this drug in these patients
Determine the response in patients treated with this drug
Correlate the induction of antibody against this drug with its pharmacokinetics in these patients
OUTLINE This is an open-label dose-escalation study
Patients receive a test dose of SS1dsFv-PE38 immunotoxin IV over 1-2 minutes on day 1 followed by SS1dsFv-PE38 immunotoxin IV over 30 minutes on days 1 3 and 5 Treatment repeats every 4 weeks for up to 3 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 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 3-15 patients will be accrued for this study
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-SS1PE-002 | None | None | None |
| NCI-03-C-0243 | None | None | None |
| NCI-6221 | None | None | None |