Trials / Completed
CompletedNCT00066651
Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors
Phase I Study Of SS1(dsFv)-PE38 Anti-Mesothelin Immunotoxin In Advanced Malignancies: I.V. Infusion QOD Dosing
- 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 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.
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
- 2003-07-01
- First posted
- 2003-08-07
- Last updated
- 2015-04-30
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00066651. Inclusion in this directory is not an endorsement.