Lung Cancer Clinical Trial
Official title:
Phase I Study Of SS1(dsFv)-PE38 (SS1P) Anti-Mesothelin Immunotoxin in Advanced Malignancies: Continuous Infusion X 10 Days
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.
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.
;
Masking: Open Label, Primary Purpose: Treatment
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