NCT00005858

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2000

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2000

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2000

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
Last Updated

November 4, 2019

Status Verified

October 1, 2019

Enrollment Period

3.7 years

First QC Date

June 2, 2000

Last Update Submit

October 31, 2019

Conditions

Bladder CancerBreast CancerColorectal CancerLung CancerOvarian CancerPancreatic Cancer

Keywords

stage III colon cancerstage IV colon cancerstage IV breast cancerstage IIIA breast cancerrecurrent breast cancerstage IIIB breast cancerrecurrent non-small cell lung cancerstage II pancreatic cancerstage III pancreatic cancerrecurrent pancreatic cancerrecurrent colon cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancerrecurrent ovarian epithelial cancerstage III bladder cancerrecurrent bladder cancerstage IV bladder cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancerovarian stromal cancerstage III ovarian germ cell tumorstage IV ovarian germ cell tumorrecurrent ovarian germ cell tumorborderline ovarian surface epithelial-stromal tumorovarian sarcomamale breast cancerstage IV pancreatic cancer

Study Arms (1)

Arm I

EXPERIMENTAL

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.

Biological: LMB-9 immunotoxin

Interventions

LMB-9 immunotoxinBIOLOGICAL
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Male or female Performance status: * ECOG 0-1 Life expectancy: * At least 3 months Hematopoietic: * Absolute granulocyte count greater than 1,200/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * 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 Renal: * Creatinine no greater than 1.4 mg/dL * Creatinine clearance greater than 60 mL/min * Proteinuria less than 1 g/24 hours Cardiovascular: * No history of coronary artery disease * No cardiac arrhythmia requiring therapy * No New York Heart Association class II-IV congestive heart failure Pulmonary: * Pulmonary function test required if significant smoking history, possible pulmonary disease, or lung cancer * FEV1 and FVC at least 65% predicted Other: * 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 PRIOR CONCURRENT THERAPY: Chemotherapy: * At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered Endocrine therapy: * At least 3 weeks since prior hormonal therapy Radiotherapy: * At least 3 weeks since prior radiotherapy and recovered

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

Sponsors & Collaborators

Study Sites (2)

Marlene and Stewart Greenebaum Cancer Center, University of Maryland

Baltimore, Maryland, 21201, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Urinary Bladder NeoplasmsBreast NeoplasmsColorectal NeoplasmsLung NeoplasmsOvarian NeoplasmsPancreatic NeoplasmsColonic NeoplasmsCarcinoma, Non-Small-Cell LungCarcinoma, Ovarian EpithelialBreast Neoplasms, Male

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleGenital Neoplasms, FemaleGenital DiseasesEndocrine System DiseasesGonadal DisordersPancreatic DiseasesCarcinoma, BronchogenicBronchial NeoplasmsCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Judith E. Karp, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2000

First Posted

January 27, 2003

Study Start

April 1, 2000

Primary Completion

December 1, 2003

Study Completion

December 1, 2003

Last Updated

November 4, 2019

Record last verified: 2019-10

Locations

US(2)