LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, or Rectal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Colorectal Cancer, Esophageal Cancer, Gastric Cancer, Pancreatic Cancer

Intervention / Treatment
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* Biological: LMB-9 immunotoxin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: LMB-9 immunotoxin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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