Immunotoxin Therapy in Treating Patients With Advanced Cancer
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|ClinicalTrials.gov Identifier: NCT00006981|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 30, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer Fallopian Tube Cancer Head and Neck Cancer Lung Cancer Malignant Mesothelioma Ovarian Cancer Pancreatic Cancer Primary Peritoneal Cavity Cancer||Biological: SS1(dsFv)-PE38 immunotoxin||Phase 1|
- Determine the maximum tolerated dose and toxic effects of SS1(dsFv)-PE38 immunotoxin in patients with advanced malignancies that express mesothelin.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study Of SS1(dsFv)-PE38 (SS1P) Anti-Mesothelin Immunotoxin in Advanced Malignancies: Continuous Infusion X 10 Days|
|Study Start Date :||December 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006981
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|Study Chair:||Robert Kreitman, MD||National Cancer Institute (NCI)|