Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, or Rectal Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed 18 and over NCI UFMC-431 UFMC-IND-7697, UFMC-NSC-691236, NCI-431, EU-20120, NCT00010270, 431

Objectives

1. 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.
2. Determine the maximum tolerated dose of this drug in these patients.
3. Determine the clinical response of patients treated with this drug.
4. Determine the pharmacokinetics of this drug in these patients.

Entry Criteria

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

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• At least 3 months

Hematopoietic:

• Platelet count greater than 100,000/mm³
• Absolute granulocyte count greater than 1,200/mm³

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:

• FEV₁ 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

Expected Enrollment

A total of 40-50 patients will be accrued for this study within 1-2 years.

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.

Trial Contact Information

Trial Lead Organizations

Universitaetsklinikum Freiburg

Peter Hafkemeyer, MD, Protocol chair		Ph: 49-7641-454-2266

Registry Information
Official Title		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
Trial Start Date		2001-04-09
Registered in ClinicalTrials.gov		NCT00010270
Date Submitted to PDQ		2001-01-02
Information Last Verified		2007-01-15

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