Phase I Study Of SS1(dsFv)-PE38 (SS1P) Anti-Mesothelin Immunotoxin in Advanced Malignancies: Continuous Infusion X 10 Days
- Determine the maximum tolerated dose and toxic effects of SS1(dsFv)-PE38 immunotoxin in
patients with advanced malignancies that express mesothelin.
- 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
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.
Masking: Open Label, Primary Purpose: Treatment
Robert Kreitman, MD
National Cancer Institute (NCI)
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|