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

This study is ongoing, but not recruiting participants.
Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, or Rectal Cancer
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
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.

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 Phase Phase I
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Colorectal Cancer
Esophageal Cancer
Gastric Cancer
Pancreatic Cancer
Intervention  Drug: LMB-9 immunotoxin
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  50
Start Date  April 2001
Completion Date
Eligibility Criteria 

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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  Germany
Administrative Information Fields
NCT ID  NCT00010270
Organization ID CDR0000068462
Secondary IDs †† UFMC-431, UFMC-IND-7697, UFMC-NSC-691236, NCI-431, EU-20120
Study Sponsor  University Hospital Freiburg
Collaborators †† National Cancer Institute (NCI)
Investigators 
Study Chair:     Peter Hafkemeyer, MD     Kreiskrankenhaus Emmendingen    
Information Provided By National Cancer Institute (NCI)
Verification Date January 2007
First Received Date  February 2, 2001
Last Updated Date July 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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