Immunotoxin Therapy in Treating Patients With Advanced Cancer
- Conditions
- Primary Peritoneal Cavity CancerMalignant MesotheliomaPancreatic CancerCervical CancerOvarian CancerFallopian Tube CancerHead and Neck CancerLung Cancer
- Registration Number
- NCT00006981
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
🇺🇸Bethesda, Maryland, United States