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LMB-9 Immunotoxin in Treating Patients With Advanced Colon, Breast, Non-Small Cell Lung, Bladder, Pancreatic, or Ovarian Cancer

This study has been completed.
Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  LMB-9 Immunotoxin in Treating Patients With Advanced Colon, Breast, Non-Small Cell Lung, Bladder, Pancreatic, or Ovarian Cancer
Official Title  Phase I Study of LMB-9, a Recombinant Disulfide Stabilized Anti-Lewis Y Immunotoxin Admistered by Continuous Infusion
Brief Summary

RATIONALE: The LMB-9 immunotoxin can locate tumor cells and kill them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of LMB-9 immunotoxin in treating patients who have advanced colon, breast, non-small cell lung, bladder, pancreatic, or ovarian cancer.

Detailed Description

OBJECTIVES:

  • Determine the maximum tolerated dose of LMB-9 immunotoxin in patients with advanced colon, breast, non-small cell lung, bladder, pancreas, or ovarian cancer.
  • Assess the toxicity and pharmacokinetics of this treatment regimen in these patients.
  • Determine the clinical responses in patients treated with this regimen.

OUTLINE: This is a dose-escalation study.

Patients receive LMB-9 immunotoxin IV continuously for 10 days. Treatment continues every 30 days 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 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 3-25 patients will be accrued for this study within 12-24 months.

Study Phase Phase I
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Bladder Cancer
Breast Cancer
Colorectal Cancer
Lung Cancer
Ovarian 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  Completed
Enrollment 
Start Date  April 2000
Completion Date
Eligibility Criteria 

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed advanced colon, breast, non-small cell lung, bladder, pancreas, or ovarian cancer refractory to standard treatment or for which no effective standard therapy exists
  • Expresses Lewis Y antigen
  • Evidence of disease progression
  • B3 antigen on the surface of more than 30% of the tumor cells determined by immunohistochemistry
  • No neutralizing antibodies to LMB-9 immunotoxin
  • No untreated CNS metastases
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Male or female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-1

Life expectancy:

  • At least 3 months

Hematopoietic:

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

Hepatic:

  • Bilirubin no greater than 1.5 times normal
  • SGOT and SGPT no greater than 2.5 times upper limit of normal (liver metastases allowed)
  • Albumin at least 3.0 g/dL
  • No prior liver disease (e.g., alcohol liver disease)
  • Hepatitis B and C negative

Renal:

  • Creatinine no greater than 1.4 mg/dL
  • Creatinine clearance greater than 60 mL/min
  • Proteinuria less than 1 g/24 hours

Cardiovascular:

  • No history of coronary artery disease
  • No cardiac arrhythmia requiring therapy
  • No New York Heart Association class II-IV congestive heart failure

Pulmonary:

  • Pulmonary function test required if significant smoking history, possible pulmonary disease, or lung cancer
  • FEV1 and FVC at least 65% predicted

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No known seizure disorders
  • No urinary tract infection
  • No other concurrent malignancy
  • No active peptic ulcer disease
  • No known allergy to omeprazole
  • No contraindication to pressor therapy
  • No other concurrent medical or psychological condition that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) 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  United States
Administrative Information Fields
NCT ID  NCT00005858
Organization ID CDR0000067885
Secondary IDs †† MSGCC-9981, MSGCC-IRB-0200123, NCI-511
Study Sponsor  University of Maryland Greenebaum Cancer Center
Collaborators †† National Cancer Institute (NCI)
Investigators 
Study Chair:     Judith E. Karp, MD     Sidney Kimmel Comprehensive Cancer Center    
Information Provided By National Cancer Institute (NCI)
Verification Date March 2003
First Received Date  June 2, 2000
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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