LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, or Rectal Cancer
This trial is active, not recruiting.
|Conditions||colorectal cancer, esophageal cancer, gastric cancer, pancreatic cancer|
|Sponsor||University Hospital Freiburg|
|Collaborator||National Cancer Institute (NCI)|
|Start date||April 2001|
|Trial size||50 participants|
|Trial identifier||NCT00010270, CDR0000068462, EU-20120, NCI-431, UFMC-431, UFMC-IND-7697, UFMC-NSC-691236|
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.
Male or female participants at least 18 years old.
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
|Official title||A Phase I Study Of LMB-9, A Recombinant Disulfide Stabilized Anti-Lewis Y Immonutoxin Administered By 5-Days Continuous Infusion For Patients With Colorectal Adenocarcinoma|
|Description||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.|
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