NCT00010270

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2001

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2001

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

December 19, 2013

Status Verified

January 1, 2007

First QC Date

February 2, 2001

Last Update Submit

December 18, 2013

Conditions

Colorectal CancerEsophageal CancerGastric CancerPancreatic Cancer

Keywords

stage IV colon cancerstage IV rectal cancerrecurrent colon cancerrecurrent rectal canceradenocarcinoma of the colonstage III pancreatic cancerstage II pancreatic cancerrecurrent pancreatic canceradenocarcinoma of the pancreasstage IV gastric canceradenocarcinoma of the stomachrecurrent gastric canceradenocarcinoma of the esophagusstage IV esophageal cancerstage III esophageal cancerrecurrent esophageal cancerstage II esophageal canceradenocarcinoma of the rectumstage III colon cancerstage III rectal cancerstage III gastric cancerstage IV pancreatic cancer

Interventions

LMB-9 immunotoxinBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Universitaetsklinikum Freiburg

Freiburg im Breisgau, D-79106, Germany

Location

MeSH Terms

Conditions

Colorectal NeoplasmsEsophageal NeoplasmsStomach NeoplasmsPancreatic NeoplasmsColonic NeoplasmsRectal NeoplasmsAdenocarcinoma Of Esophagus

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesHead and Neck NeoplasmsEsophageal DiseasesStomach DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Peter Hafkemeyer, MD

    Kreiskrankenhaus Emmendingen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 2, 2001

First Posted

January 27, 2003

Study Start

April 1, 2001

Last Updated

December 19, 2013

Record last verified: 2007-01

Locations

DE(1)