This trial is active, not recruiting.

Conditions colorectal cancer, esophageal cancer, gastric cancer, pancreatic cancer
Treatment lmb-9 immunotoxin
Phase phase 1
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose treatment

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).