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Home > "L" Clinical Trials Conditions > LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, or Rectal Cancer  LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, or Rectal Cancer
LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, or Rectal Cancer
For Condition: Gastric Cancer,Colorectal Cancer,Pancreatic Cancer,Esophageal Cancer
Status: Recruiting
Sponsor(s): University of Freiburg , National Cancer Institute (NCI)
Synopsis: RATIONALE: LMB-9 immunotoxin can locate tumor cells and kill them without harming normal cells. This may be an effective treatment for advanced pancreatic, esophageal, stomach, colon or rectal cancer. PURPOSE: Phase I trial to study the effectiveness of LMB-9 immunotoxin in treating patients who have advanced pancreatic, esophageal, stomach, colon, or rectal cancer.
Details: OBJECTIVES: - Determine the toxicity of LMB-9 immunotoxin in patients with advanced adenocarcinoma of the colon, rectum, pancreas, esophagus, or stomach with overexpression of the Lewis-Y antigen. - Determine the maximum tolerated dose of this drug in these patients. - Determine the clinical response of patients treated with this drug. - Determine the pharmacokinetics of this drug in these patients. OUTLINE: This is a dose-escalation study. Patients receive LMB-9 immunotoxin IV continuously on days 1-5. Patients with stable or responding disease after completion of the first course receive additional courses every 4-5 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of LMB-9 immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 3 weeks and then every 2 months thereafter. PROJECTED ACCRUAL: A total of 40-50 patients will be accrued for this study within 1-2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed advanced adenocarcinoma of the colon, rectum, pancreas, esophagus, or stomach that is refractory to standard treatment - Overexpression of the Lewis-Y antigen - Measurable or evaluable disease - No CNS metastasis - Metastatic liver disease from primary tumor allowed PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - At least 3 months Hematopoietic: - Platelet count greater than 100,000/mm^3 - Absolute granulocyte count greater than 1,200/mm^3 Hepatic: - Bilirubin normal - SGOT and SGPT no greater than 1.5 times upper limit of normal - Hepatitis B or C antigen negative - No liver disease (e.g., alcohol liver disease) - Albumin at least 3.0 g/dL Renal: - Creatinine no greater than 1.4 mg/dL - Creatinine clearance at least 60 mL/min - Proteinuria no greater than 1 g/24 hours (grade II toxicity-like) Cardiovascular: - No prior coronary artery disease - No New York Heart Association class II, III, or IV congestive heart failure - No arrhythmia requiring treatment Pulmonary: - FEV_1 and FVC greater than 65% predicted Other: - No other concurrent malignancy - No active peptic ulcer disease - No known allergy to omeprazole - No known seizure disorder - No concurrent medical or psychiatric condition that would preclude study participation - No contraindication to pressor therapy - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: - At least 3 weeks since prior hormonal therapy Radiotherapy: - At least 3 weeks since prior radiotherapy and recovered Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PeterHafkemeyer, Study Chair, University of Freiburg
Universitats Klinikum Freiburg *Recruiting*
Freiburg, , D-79106
Germany
Recruiting Peter Hafkemeyer 49-761-270-3406
Additional Information:
Study ID Numbers: CDR0000068462; UFMC-IND-7697,NCI-431,UFMC-NSC-691236,UFMC-431,EU-20120
Study Start Date:
Record last reviewed: September 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00010270
Other Gastric Cancer Studies:
1. Intraperitoneal and Intravenous Gemcitabine, Radiotherapy and Surgery for Advanced Cancer of the Pancreas
2. Gemcitabine With or Without Dalteparin in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
3. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Gastrointestinal Cancer
4. LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, or Rectal Cancer
5. Diagnostic and Genetic Study to Identify Pancreatic Lesions in Patients With Von Hippel-Lindau Syndrome
Related Studies:
Other Gastric Cancer Clinical Trials
Other Clinical Trials
Other Freiburg Clinical Trials
LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, or Rectal Cancer
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