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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00010270
Recruitment Status : Unknown
Verified January 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : December 19, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Esophageal Cancer Gastric Cancer Pancreatic Cancer Biological: LMB-9 immunotoxin Phase 1

Detailed Description:


  • 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  (Clinical Trial)
Estimated Enrollment : 50 participants
Primary Purpose: Treatment
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
Study Start Date : April 2001

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Performance status:

  • ECOG 0-1

Life expectancy:

  • 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


Biologic therapy:

  • Not specified


  • 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


  • At least 3 weeks since prior radiotherapy and recovered


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00010270

Universitaetsklinikum Freiburg
Freiburg, Germany, D-79106
Sponsors and Collaborators
University Hospital Freiburg
National Cancer Institute (NCI)
Study Chair: Peter Hafkemeyer, MD Kreiskrankenhaus Emmendingen Identifier: NCT00010270     History of Changes
Other Study ID Numbers: CDR0000068462
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: January 2007

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
adenocarcinoma of the colon
stage III pancreatic cancer
stage II pancreatic cancer
recurrent pancreatic cancer
adenocarcinoma of the pancreas
stage IV gastric cancer
adenocarcinoma of the stomach
recurrent gastric cancer
adenocarcinoma of the esophagus
stage IV esophageal cancer
stage III esophageal cancer
recurrent esophageal cancer
stage II esophageal cancer
adenocarcinoma of the rectum
stage III colon cancer
stage III rectal cancer
stage III gastric cancer
stage IV pancreatic cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Esophageal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Immunologic Factors
Physiological Effects of Drugs