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
Data Collection
Colonic Diseases+19
+ Colonic Neoplasms
+ Digestive System Diseases
Treatment Study
Summary
Study start date: April 1, 2001
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Universitaetsklinikum Freiburg
Freiburg im Breisgau, GermanyOpen Universitaetsklinikum Freiburg in Google Maps