LMB-9 Immunotoxin In Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, Or Rectal Cancer

Study Overview

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

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.

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.

Colorectal Cancer
Esophageal Cancer
Gastric Cancer
Pancreatic Cancer

BIOLOGICAL: LMB-9 immunotoxin

CDR0000068462
UFMC-431
UFMC-IND-7697
UFMC-NSC-691236
NCI-431
EU-20120

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2001-02-02	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-12-18
First Submitted that Met QC Criteria 2003-01-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-12-19
First Posted (ESTIMATED) 2003-01-27	Results First Posted N/A	Last Verified 2007-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

18 and over

ECOG 0-1

At least 3 months

Platelet count greater than 100,000/mm^3
Absolute granulocyte count greater than 1,200/mm^3

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

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)

No prior coronary artery disease
No New York Heart Association class II, III, or IV congestive heart failure
No arrhythmia requiring treatment

FEV\_1 and FVC greater than 65% predicted

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

Not specified

At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

At least 3 weeks since prior hormonal therapy

At least 3 weeks since prior radiotherapy and recovered

Not specified

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

STUDY_CHAIR: Peter Hafkemeyer, MD, Kreiskrankenhaus Emmendingen

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record