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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00010270
• Other study ID #: CDR0000068462
• Secondary ID: UFMC-431UFMC-IND
• Status: Active, not recruiting
• Phase: Phase 1
• First received: February 2, 2001
• Last updated: December 18, 2013
• Start date: April 2001

Study information

• Verified date: January 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: LMB-9 immunotoxin can locate tumor cells and kill them without harming normal cells. This may be an effective treatment for advanced pancreatic, esophageal, stomach, colon or rectal cancer.

PURPOSE: Phase I trial to study the effectiveness of LMB-9 immunotoxin in treating patients who have advanced pancreatic, esophageal, stomach, colon, or rectal cancer.

Description:

OBJECTIVES:

• 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.

• Determine the maximum tolerated dose of this drug in these patients.

• Determine the clinical response of patients treated with this drug.

• Determine the pharmacokinetics of this drug in these patients.

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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• At least 3 months

Hematopoietic:

• Platelet count greater than 100,000/mm^3

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

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:

• FEV_1 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

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms
• Stomach Neoplasms

Intervention

Biological:
• LMB-9 immunotoxin

Locations

Country	Name	City	State
Germany	Universitaetsklinikum Freiburg	Freiburg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Freiburg	National Cancer Institute (NCI)

Country where clinical trial is conducted

Germany,