LMB-9 Immunotoxin in Treating Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00019435|
Recruitment Status : Completed
First Posted : May 6, 2003
Last Update Posted : April 29, 2015
RATIONALE: The LMB-9 immunotoxin may be able to locate tumor cells and kill them without harming normal cells. This may be an effective treatment for advanced solid tumors.
PURPOSE: Phase I trial to study the effectiveness of LMB-9 immunotoxin in treating patients who have advanced solid tumors that have not responded to standard therapy.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer Breast Cancer Colorectal Cancer Esophageal Cancer Gastric Cancer Lung Cancer Pancreatic Cancer||Biological: LMB-9 immunotoxin||Phase 1|
OBJECTIVES: I. Determine the toxic effects and the pharmacokinetics of LMB-9 immunotoxin in patients with advanced solid tumors that express Lewis Y antigen. II. Evaluate the anti-tumor activity and the immunogenicity of this treatment regimen in these patients.
OUTLINE: This is a dose-escalation study. Patients receive LMB-9 immunotoxin IV over 30 minutes on days 1, 3, and 5. Patients with negative neutralizing antibody to LMB-9 immunotoxin with stable or responding disease receive additional courses every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of LMB-9 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. Once the MTD is determined, an additional cohort of 6 patients may be treated at the MTD. Patients are followed at 1 month and then every 2 months thereafter.
PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued within 12-24 months.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase I Study of LMB-9, a Recombinant Disulfide Stabilized Immunotoxin for Advanced Carcinomas That Express Lewis Y Antigen|
|Study Start Date :||May 1998|
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): NCT00019435
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||Ira Pastan, MD||National Cancer Institute (NCI)|