NCT00019435

Brief Summary

RATIONALE: The LMB-9 immunotoxin may be able to locate tumor cells and kill them without harming normal cells. This may be an effective treatment for advanced solid tumors. PURPOSE: Phase I trial to study the effectiveness of LMB-9 immunotoxin in treating patients who have advanced solid tumors that have not responded to standard therapy.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 1998

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

May 6, 2003

Completed
Last Updated

April 29, 2015

Status Verified

April 1, 2007

First QC Date

July 11, 2001

Last Update Submit

April 28, 2015

Conditions

Bladder CancerBreast CancerColorectal CancerEsophageal CancerGastric CancerLung CancerPancreatic Cancer

Keywords

stage IV colon cancerstage IV breast cancerrecurrent breast cancerstage IV gastric cancerrecurrent gastric cancerrecurrent non-small cell lung cancerrecurrent pancreatic cancerrecurrent colon cancerstage IV esophageal cancerrecurrent esophageal cancerrecurrent bladder cancerstage IV bladder cancerstage IV non-small cell lung 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 solid tumor refractory to standard treatment or for which no effective standard therapy exists Bladder cancer Breast cancer Colon cancer Esophageal cancer Gastric cancer Non-small cell lung cancer Pancreatic cancer Evaluable or measurable disease B3 antigen present on more than 30% of tumor cells No prior or concurrent CNS metastasis Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance status: ECOG 0-1 Life expectancy: At least 3 months Hematopoietic: Granulocyte count greater than 1,200/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin normal SGOT/SGPT less than 5 times upper limit of normal Albumin at least 3.0 g/dL No history of liver disease No positive hepatitis B or C antigen Renal: Creatinine no greater than 1.4 mg/dL Cardiovascular: No history of coronary artery disease No New York Association class II-IV heart disease No arrhythmia requiring treatment No contraindications to pressor therapy Pulmonary: FEV1 and FVC greater than 65% of predicted value Pulmonary function test required of patients with significant smoking history or possible pulmonary disease Other: No active peptic ulcer disease No known allergy to omeprazole No history of seizure disorders No other concurrent malignancy No concurrent medical or psychiatric condition that would preclude study 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 mitomycin and nitrosourea) 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)

Medicine Branch

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Urinary Bladder NeoplasmsBreast NeoplasmsColorectal NeoplasmsEsophageal NeoplasmsStomach NeoplasmsLung NeoplasmsPancreatic NeoplasmsColonic NeoplasmsCarcinoma, Non-Small-Cell Lung

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 DiseasesHead and Neck NeoplasmsEsophageal DiseasesStomach DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • Ira Pastan, MD

    National Cancer Institute (NCI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

July 11, 2001

First Posted

May 6, 2003

Study Start

May 1, 1998

Last Updated

April 29, 2015

Record last verified: 2007-04

Locations

US(1)