LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, or Rectal Cancer
Colorectal Cancer, Esophageal Cancer, Gastric Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, stage III pancreatic cancer, stage II pancreatic cancer, recurrent pancreatic cancer, adenocarcinoma of the pancreas, stage IV gastric cancer, adenocarcinoma of the stomach, recurrent gastric cancer, adenocarcinoma of the esophagus, stage IV esophageal cancer, stage III esophageal cancer, recurrent esophageal cancer, stage II esophageal cancer, adenocarcinoma of the rectum, stage III colon cancer, stage III rectal cancer, stage III gastric cancer, stage IV pancreatic cancer
Eligibility 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
Sites / Locations
- Universitaetsklinikum Freiburg