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

December 18, 2013 updated by: University Hospital Freiburg

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Biological: LMB-9 immunotoxin

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 1

Contacts and Locations

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

Study Locations

Germany
- - Freiburg, Germany, D-79106
    - Universitaetsklinikum Freiburg

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

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

How is the study designed?

Design Details

Primary Purpose: Treatment

Collaborators and Investigators

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

Sponsor

University Hospital Freiburg

Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair: Peter Hafkemeyer, MD, Kreiskrankenhaus Emmendingen

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 Major Dates

Study Start

April 1, 2001

Study Registration Dates

First Submitted

February 2, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

December 19, 2013

Last Update Submitted That Met QC Criteria

December 18, 2013

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.