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

Primary Purpose

Colorectal Cancer, Esophageal Cancer, Gastric Cancer

Status
Unknown status
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
LMB-9 immunotoxin
Sponsored by
University Hospital Freiburg
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, stage III pancreatic cancer, stage II pancreatic cancer, recurrent pancreatic cancer, adenocarcinoma of the pancreas, stage IV gastric cancer, adenocarcinoma of the stomach, recurrent gastric cancer, adenocarcinoma of the esophagus, stage IV esophageal cancer, stage III esophageal cancer, recurrent esophageal cancer, stage II esophageal cancer, adenocarcinoma of the rectum, stage III colon cancer, stage III rectal cancer, stage III gastric cancer, stage IV pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitaetsklinikum Freiburg

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 2, 2001
Last Updated
December 18, 2013
Sponsor
University Hospital Freiburg
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00010270
Brief Title
LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, or Rectal Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Unknown status
Study Start Date
April 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Freiburg
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Esophageal Cancer, Gastric Cancer, Pancreatic Cancer
Keywords
stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, stage III pancreatic cancer, stage II pancreatic cancer, recurrent pancreatic cancer, adenocarcinoma of the pancreas, stage IV gastric cancer, adenocarcinoma of the stomach, recurrent gastric cancer, adenocarcinoma of the esophagus, stage IV esophageal cancer, stage III esophageal cancer, recurrent esophageal cancer, stage II esophageal cancer, adenocarcinoma of the rectum, stage III colon cancer, stage III rectal cancer, stage III gastric cancer, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
LMB-9 immunotoxin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Hafkemeyer, MD
Organizational Affiliation
Kreiskrankenhaus Emmendingen
Official's Role
Study Chair
Facility Information:
Facility Name
Universitaetsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
D-79106
Country
Germany

12. IPD Sharing Statement

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

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