NCT00006981

Immunotoxin Therapy in Treating Patients With Advanced Cancer

Phase I Study Of SS1(dsFv)-PE38 (SS1P) Anti-Mesothelin Immunotoxin in Advanced Malignancies: Continuous Infusion X 10 Days

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Cervical Cancer
• Fallopian Tube Cancer
• Head and Neck Cancer
• Lung Cancer
• Malignant Mesothelioma
• Ovarian Cancer
• Pancreatic Cancer
• Primary Peritoneal Cavity Cancer

Interventions

Type	Name	Description
BIOLOGICAL	SS1(dsFv)-PE38 immunotoxin

Timeline

• Start date: 2000-12-01
• First posted: 2003-01-27
• Last updated: 2015-04-30

Locations

1 site across 1 country: United States