Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors

Phase 1

Completed

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

• Registration Number: NCT00066651
• Lead Sponsor: National Cancer Institute (NCI)

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.

Detailed Description

OBJECTIVES:

Primary

* Determine the maximum tolerated dose of SS1(dsFv)-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 SS1(dsFv)-PE38 immunotoxin IV over 1-2 minutes on day 1 followed by SS1(dsFv)-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 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 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 Timeline

• Study Start: 2003-07
• Study First Submitted: 2003-08-06
• Study First Submitted QC: 2003-08-06
• Study First Posted: 2003-08-07
• Status Verified: 2006-02
• Last Update Submitted: 2015-04-29
• Last Update Posted: 2015-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support; 🇺🇸 Bethesda, Maryland, United States

Comprehensive Cancer Center at Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States