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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.
First Received: June 2, 2000   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: University of Maryland Greenebaum Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005858
  Purpose

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.


Condition Intervention Phase
Bladder Cancer
Breast Cancer
Colorectal Cancer
Lung Cancer
Ovarian Cancer
Pancreatic Cancer
Biological: LMB-9 immunotoxin
Phase I

Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of LMB-9, a Recombinant Disulfide Stabilized Anti-Lewis Y Immunotoxin Admistered by Continuous Infusion

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: April 2000
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005858

Locations
United States, Maryland
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
University of Maryland Greenebaum Cancer Center
Investigators
Study Chair: Judith E. Karp, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067885, MSGCC-9981, MSGCC-IRB-0200123, NCI-511
Study First Received: June 2, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00005858     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III colon cancer
stage IV colon cancer
stage IV breast cancer
stage IIIA breast cancer
recurrent breast cancer
stage IIIB breast cancer
recurrent non-small cell lung cancer
stage II pancreatic cancer
stage III pancreatic cancer
recurrent pancreatic cancer
recurrent colon cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
stage III bladder cancer
recurrent bladder cancer
stage IV bladder cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
ovarian stromal cancer
stage III ovarian germ cell tumor
stage IV ovarian germ cell tumor
recurrent ovarian germ cell tumor
borderline ovarian surface epithelial-stromal tumor
ovarian sarcoma
male breast cancer
stage IV pancreatic cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Urinary Tract Neoplasm
Immunologic Factors
Gonadal Disorders
Gastrointestinal Diseases
Pancreatic Neoplasms
Colonic Diseases
Urogenital Neoplasms
Breast Cancer, Male
Ovarian Diseases
Urologic Neoplasms
Rectal Diseases
Genital Diseases, Female
Soft Tissue Sarcomas
Respiratory Tract Diseases
Urologic Diseases
Lung Neoplasms
Ovarian Cancer
Bladder Neoplasm
Breast Diseases
Endocrine Gland Neoplasms
Cystocele
Ovarian Neoplasms
Digestive System Neoplasms
Skin Diseases
Urinary Bladder Diseases
Genital Neoplasms, Female
Urinary Bladder Neoplasms
Endocrine System Diseases
Breast Neoplasms

Additional relevant MeSH terms:
Thoracic Neoplasms
Immunologic Factors
Gonadal Disorders
Gastrointestinal Diseases
Pancreatic Neoplasms
Physiological Effects of Drugs
Colonic Diseases
Urogenital Neoplasms
Ovarian Diseases
Urologic Neoplasms
Rectal Diseases
Genital Diseases, Female
Neoplasms by Site
Respiratory Tract Diseases
Urologic Diseases
Lung Neoplasms
Breast Diseases
Endocrine Gland Neoplasms
Respiratory Tract Neoplasms
Ovarian Neoplasms
Digestive System Neoplasms
Skin Diseases
Urinary Bladder Diseases
Genital Neoplasms, Female
Urinary Bladder Neoplasms
Endocrine System Diseases
Breast Neoplasms
Intestinal Diseases
Pharmacologic Actions
Immunotoxins

ClinicalTrials.gov processed this record on September 03, 2009