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LMB-9 Immunotoxin in Treating Patients With Advanced Solid Tumors

This study has been completed.

Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00019435
  Purpose

RATIONALE: The LMB-9 immunotoxin may be able to locate tumor cells and kill them without harming normal cells. This may be an effective treatment for advanced solid tumors.

PURPOSE: Phase I trial to study the effectiveness of LMB-9 immunotoxin in treating patients who have advanced solid tumors that have not responded to standard therapy.


Condition Intervention Phase
Bladder Cancer
Breast Cancer
Colorectal Cancer
Esophageal Cancer
Gastric Cancer
Lung Cancer
Pancreatic Cancer
Drug: LMB-9 immunotoxin
Phase I

Genetics Home Reference related topics:   bladder cancer    breast cancer   

MedlinePlus related topics:   Bladder Cancer    Breast Cancer    Cancer    Colorectal Cancer    Esophageal Cancer    Esophagus Disorders    Lung Cancer    Pancreatic Cancer    Stomach Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase I Study of LMB-9, a Recombinant Disulfide Stabilized Immunotoxin for Advanced Carcinomas That Express Lewis Y Antigen

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

Study Start Date:   May 1998

Detailed Description:

OBJECTIVES: I. Determine the toxic effects and the pharmacokinetics of LMB-9 immunotoxin in patients with advanced solid tumors that express Lewis Y antigen. II. Evaluate the anti-tumor activity and the immunogenicity of this treatment regimen in these patients.

OUTLINE: This is a dose-escalation study. Patients receive LMB-9 immunotoxin IV over 30 minutes on days 1, 3, and 5. Patients with negative neutralizing antibody to LMB-9 immunotoxin with stable or responding disease receive additional courses every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of LMB-9 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional cohort of 6 patients may be treated at the MTD. Patients are followed at 1 month and then every 2 months thereafter.

PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued 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 solid tumor refractory to standard treatment or for which no effective standard therapy exists Bladder cancer Breast cancer Colon cancer Esophageal cancer Gastric cancer Non-small cell lung cancer Pancreatic cancer Evaluable or measurable disease B3 antigen present on more than 30% of tumor cells No prior or concurrent CNS metastasis Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance status: ECOG 0-1 Life expectancy: At least 3 months Hematopoietic: Granulocyte count greater than 1,200/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin normal SGOT/SGPT less than 5 times upper limit of normal Albumin at least 3.0 g/dL No history of liver disease No positive hepatitis B or C antigen Renal: Creatinine no greater than 1.4 mg/dL Cardiovascular: No history of coronary artery disease No New York Association class II-IV heart disease No arrhythmia requiring treatment No contraindications to pressor therapy Pulmonary: FEV1 and FVC greater than 65% of predicted value Pulmonary function test required of patients with significant smoking history or possible pulmonary disease Other: No active peptic ulcer disease No known allergy to omeprazole No history of seizure disorders No other concurrent malignancy No concurrent medical or psychiatric condition that would preclude study 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 mitomycin and nitrosourea) 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: NCT00019435

Locations
United States, Maryland
Medicine Branch    
      Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

Investigators
Study Chair:     Ira Pastan, MD     National Cancer Institute (NCI)    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000066180, NCI-98-C-0078A, NCI-MB-400, NCI-T98-0005
First Received:   July 11, 2001
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00019435
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer  
stage IV breast cancer  
recurrent breast cancer  
stage IV gastric cancer  
recurrent gastric cancer  
recurrent non-small cell lung cancer  
recurrent pancreatic cancer  
recurrent colon cancer
stage IV esophageal cancer
recurrent esophageal cancer
recurrent bladder cancer
stage IV bladder cancer
stage IV non-small cell lung cancer
stage IV pancreatic cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Gastrointestinal Diseases
Pancreatic Neoplasms
Esophageal Neoplasms
Colonic Diseases
Urogenital Neoplasms
Urologic Neoplasms
Rectal Diseases
Stomach Diseases
Respiratory Tract Diseases
Urologic Diseases
Lung Neoplasms
Stomach Neoplasms
Esophageal neoplasm
Breast Diseases
Bladder neoplasm
Endocrine Gland Neoplasms
Non-small cell lung cancer
Digestive System Neoplasms
Esophageal disorder
Skin Diseases
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Endocrine System Diseases
Breast Neoplasms
Stomach cancer
Intestinal Diseases
Immunotoxins
Recurrence
Intestinal Neoplasms

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




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