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
Collecte de données
Maladies du côlon+19
+ Néoplasmes du côlon
+ Maladies du système digestif
Étude thérapeutique
Résumé
Date de début de l'étude : 1 avril 2001
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.50 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Universitaetsklinikum Freiburg
Freiburg im Breisgau, GermanyOuvrir Universitaetsklinikum Freiburg dans Google Maps