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Phase I Study of LMB-9, a Recombinant Disulfide Stabilized Immunotoxin for Advanced Carcinomas that Express Lewis Y Antigen Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Phase I Study of LMB-9, a Recombinant Disulfide Stabilized Immunotoxin for Advanced Carcinomas that Express Lewis Y Antigen conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Phase I Study of LMB-9, a Recombinant Disulfide Stabilized Immunotoxin for Advanced Carcinomas that Express Lewis Y Antigen Clinical research trials and Phase I Study of LMB-9, a Recombinant Disulfide Stabilized Immunotoxin for Advanced Carcinomas that Express Lewis Y Antigen healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Phase I Study of LMB-9, a Recombinant Disulfide Stabilized Immunotoxin for Advanced Carcinomas that Express Lewis Y Antigen. Phase I Study of LMB-9, a Recombinant Disulfide Stabilized Immunotoxin for Advanced Carcinomas that Express Lewis Y Antigen Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Phase I Study of LMB-9, a Recombinant Disulfide Stabilized Immunotoxin for Advanced Carcinomas that Express Lewis Y Antigen clinical trial. Test subjects typically receive the most effective healthcare possible for their Phase I Study of LMB-9, a Recombinant Disulfide Stabilized Immunotoxin for Advanced Carcinomas that Express Lewis Y Antigen condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase I Study of LMB-9, a Recombinant Disulfide Stabilized Immunotoxin for Advanced Carcinomas that Express Lewis Y Antigen  Phase I Study of LMB-9, a Recombinant Disulfide Stabilized Immunotoxin for Advanced Carcinomas that Express Lewis Y Antigen
Phase I Study of LMB-9, a Recombinant Disulfide Stabilized Immunotoxin for Advanced Carcinomas that Express Lewis Y Antigen
For Condition: Breast Neoplasm,Colonic Neoplasm,Lung Neoplasm,Ovarian Neoplasm,Stomach Neoplasm
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This is a Phase I study of LMB-9 for advanced carcinomas that express Lewis Y antigen. LMB-9 is a disulfide stabilized, recombinant immunotoxin composed of the variable regions of the light and heavy chains of monoclonal antibody B3, fused to PE38, a truncated form of Pseudomonas exotoxin. The primary objective of this study is to determine the dose-limiting toxicities and the pharmacokinetics of LMB-9 in cancer patients. Other objectives are to evaluate the anti-tumor activity and the immunogenicity of this agent.
Details: This is a Phase I study of LMB-9 for advanced carcinomas that express Lewis Y antigen. LMB-9 is a disulfide stabilized, recombinant immunotoxin composed of the variable regions of the light and heavy chains of monoclonal antibody B3, fused to PE38, a truncated form of Pseudomonas exotoxin. The primary objective of this study is to determine the dose-limiting toxicities and the pharmacokinetics of LMB-9 in cancer patients. Other objectives are to evaluate the anti-tumor activity and the immunogenicity of this agent.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Eligible patients are limited to advanced stage tumor patients with histologically or cytologically proven evaluable or measurable disease who are refractory to standard treatment for their malignancy or for whom no effective standard therapy exists. Presence of B3 antigen on the surface of greater than 30% of the tumor cells are eligible. Immunohistochemistry will be determined using paraffin embedded tissue blocks. Patients must be able to give informed consent after being told the potential risks and benefits, as well as the investigational nature of the study. ECOG performance status of 0 or 1 and a minimum life expectancy of 3 months. Patients must have normal renal function (Creatinine equal to 1.4 mg/dl), SGOT and SGPT less than 5 times the upper limits of normal. Total bilirubin, within normal limits; AGC greater than 1,200 per mm(3); platelets greater than 100,000 per mm(3). Patients must have recovered from the toxic effects of prior chemotherapy or radiation therapy. At least 3 weeks must have elapsed since the last dose of chemotherapy, hormonal therapy or radiation therapy. At least six weeks must have elapsed since the last dose of Mitomycin C and a nitrosourea. Patients must be equal to 18 years old. EXCLUSION CRITERIA: Patients must not have neutralizing antibodies to LMB-9. Patients with positive hepatitis B or C antigen or history of any other prior liver disease (e.g. alcohol liver disease) are excluded. Patients with metastatic liver disease from primary tumor, with SGOT and SGPT equal to 1.5 x normal will be eligible for the study. Patients must not have active peptic ulcer disease. Patients must not have a known allergy to omeprazole. Patients must not have a history of coronary artery disease, NY class II-IV CHF, arrhythmia requiring treatment or any contraindication to pressor therapy. Pulmonary Function Test will be required for patients with significant smoking history or suspicion of pulmonary disease. Patients with FEV1 and FVC less than or equal to 65% of the predicted value are excluded. Baseline serum albumin of greater than or equal to 3.0 g/dl. Patients with history of CNS metastasis and/or known seizure disorders, or current malignancy are excluded. Patients with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results are excluded. Pregnant or breastfeeding patients are excluded. Patients of childbearing potential must agree to use an effective method of contraception.
Total Enrollment: 30
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 980078; 98-C-0078
Study Start Date: March 12, 1998
Record last reviewed: March 18, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001691
Other Colonic Neoplasm Studies:
1. Phase I Study of LMB-9, a Recombinant Disulfide Stabilized Immunotoxin for Advanced Carcinomas that Express Lewis Y Antigen
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Phase I Study of LMB-9, a Recombinant Disulfide Stabilized Immunotoxin for Advanced Carcinomas that Express Lewis Y Antigen
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