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Phase I Study of LMB-9, a Recombinant Disulfide Stabilized Immunotoxin for Advanced Carcinomas That Express Lewis Y Antigen

Phase 1
18 Years
Not Enrolling
Bladder Cancer, Breast Cancer, Colorectal Cancer, Esophageal Cancer, Gastric Cancer, Lung Cancer, Pancreatic Cancer

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Trial Information

Phase I Study of LMB-9, a Recombinant Disulfide Stabilized Immunotoxin for Advanced Carcinomas That Express Lewis Y Antigen

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.

Inclusion 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

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Ira Pastan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

May 1998

Completion Date:

Related Keywords:

  • Bladder Cancer
  • Breast Cancer
  • Colorectal Cancer
  • Esophageal Cancer
  • Gastric Cancer
  • Lung Cancer
  • Pancreatic Cancer
  • 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
  • Urinary Bladder Neoplasms
  • Breast Neoplasms
  • Colorectal Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Lung Neoplasms
  • Stomach Neoplasms
  • Pancreatic Neoplasms



Medicine Branch Bethesda, Maryland  20892