Clinical Trial: Immunotoxin Therapy in Treating Patients With Advanced Cancer
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase I Study Of SS1(dsFv)-PE38 (SS1P) Anti-Mesothelin Immunotoxin in Advanced Malignancies: Continuous Infusion X 10 Days
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 Summary:
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and toxic effects of SS1(dsFv)-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 SS1(dsFv)-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 SS1(dsFv)-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.
Sponsor: National Cancer Institute (NCI)
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: National Cancer Institute (NCI)
Dates:
Date Received: December 6, 2000
Date Started: December 2000
Date Completion:
Last Updated: April 29, 2015
Last Verified: May 2005
