LMB-9 Immunotoxin In Treating Patients With Advanced Colon, Breast, Non-small Cell Lung, Bladder, Pancreatic, Or Ovarian Cancer

Study Overview

LMB-9 Immunotoxin in Treating Patients With Advanced Colon, Breast, Non-small Cell Lung, Bladder, Pancreatic, or Ovarian Cancer

Phase I trial to study the effectiveness of LMB-9 immunotoxin in treating patients who have advanced colon, breast, non-small cell lung, bladder, pancreatic, or ovarian cancer. The LMB-9 immunotoxin can locate tumor cells and kill them without harming normal cells.

OBJECTIVES: I. Determine the maximum tolerated dose of LMB-9 immunotoxin in patients with advanced colon, breast, non-small cell lung, bladder, pancreas, or ovarian cancer. II. Assess the toxicity and pharmacokinetics of this treatment regimen in these patients. III. Determine the clinical responses in patients treated with this regimen. OUTLINE: This is a dose-escalation study. Patients receive LMB-9 immunotoxin IV continuously for 10 days. Treatment continues every 30 days 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 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 3 weeks and then every 2 months thereafter.

Bladder Cancer
Breast Cancer
Colorectal Cancer
Lung Cancer
Ovarian Cancer
Pancreatic Cancer

BIOLOGICAL: LMB-9 immunotoxin

MSGCC-9981
CDR0000067885 (REGISTRY Identifier) (REGISTRY: PDQ (Physician Data Query))
MSGCC-IRB-0200123
NCI-511

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2000-06-02	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-10-31
First Submitted that Met QC Criteria 2003-01-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-11-04
First Posted (ACTUAL) 2003-01-27	Results First Posted N/A	Last Verified 2019-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Arm I Patients receive LMB-9 immunotoxin IV continuously for 10 days. Treatment continues every 30 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of LMB-9 immunotoxin until the maximum tole	BIOLOGICAL: LMB-9 immunotoxin

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Arm I

Patients receive LMB-9 immunotoxin IV continuously for 10 days. Treatment continues every 30 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of LMB-9 immunotoxin until the maximum tole

BIOLOGICAL: LMB-9 immunotoxin

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically or cytologically confirmed advanced colon, breast, non-small cell lung, bladder, pancreas, or ovarian cancer refractory to standard treatment or for which no effective standard therapy exists
Expresses Lewis Y antigen
Evidence of disease progression
B3 antigen on the surface of more than 30% of the tumor cells determined by immunohistochemistry
No neutralizing antibodies to LMB-9 immunotoxin
No untreated CNS metastases

18 and over

Male or female

ECOG 0-1

At least 3 months

Absolute granulocyte count greater than 1,200/mm^3
Platelet count greater than 100,000/mm^3

Bilirubin no greater than 1.5 times normal
SGOT and SGPT no greater than 2.5 times upper limit of normal (liver metastases allowed)
Albumin at least 3.0 g/dL
No prior liver disease (e.g., alcohol liver disease)
Hepatitis B and C negative

Creatinine no greater than 1.4 mg/dL
Creatinine clearance greater than 60 mL/min
Proteinuria less than 1 g/24 hours

No history of coronary artery disease
No cardiac arrhythmia requiring therapy
No New York Heart Association class II-IV congestive heart failure

Pulmonary function test required if significant smoking history, possible pulmonary disease, or lung cancer
FEV1 and FVC at least 65% predicted

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No known seizure disorders
No urinary tract infection
No other concurrent malignancy
No active peptic ulcer disease
No known allergy to omeprazole
No contraindication to pressor therapy
No other concurrent medical or psychological condition that would preclude study

At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered

At least 3 weeks since prior hormonal therapy

At least 3 weeks since prior radiotherapy and recovered

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

STUDY_CHAIR: Judith E. Karp, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record