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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.
Study NCT00010270   Information provided by National Cancer Institute (NCI)
First Received: February 2, 2001   Last Updated: February 6, 2009   History of Changes

February 2, 2001
February 6, 2009
April 2001
 
 
 
Complete list of historical versions of study NCT00010270 on ClinicalTrials.gov Archive Site
 
 
 
LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, or Rectal Cancer
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.

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.

Phase I
Interventional
Treatment
  • Colorectal Cancer
  • Esophageal Cancer
  • Gastric Cancer
  • Pancreatic Cancer
Biological: LMB-9 immunotoxin
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
50
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00010270
 
CDR0000068462, UFMC-431, UFMC-IND-7697, UFMC-NSC-691236, NCI-431, EU-20120
University Hospital Freiburg
National Cancer Institute (NCI)
Study Chair: Peter Hafkemeyer, MD Kreiskrankenhaus Emmendingen
National Cancer Institute (NCI)
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP