Trials Sponsors Conditions Drugs Pricing

Conditions

Brain and Central Nervous System Tumors

Keywords

leptomeningeal metastases

Interventions

LMB-7 immunotoxinBiological

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically proven primary intracranial or extraneural neoplasm with leptomeningeal metastases At least 30% of malignant cells in the cerebrospinal fluid, primary tumor, or metastatic tumor must react with the B3 mouse monoclonal antibody PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: ANC greater than 1000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 1.2 mg/dL Pulmonary: DLCO at least 60 Other: No neutralizing antibodies to Pseudomonas exotoxin Not pregnant or nursing Not allergic to penicillin PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No chemotherapy within past 4 weeks (6 weeks for nitrosoureas) unless there is evidence of disease progression in CNS No concurrent chemotherapy Endocrine therapy: Patients receiving corticosteroids must be on stable dose for 10 days prior to entry Radiotherapy: No radiotherapy to disease site within past 3 months unless there is evidence of disease progression in CNS No concurrent radiotherapy Surgery: Not specified

Sponsors & Collaborators

National Cancer Institute (NCI)
NIHcollaborator
Duke University
Otherlead

Study Sites (2)

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107, United States

MeSH Terms

Conditions

Central Nervous System NeoplasmsMeningeal Carcinomatosis

Interventions

immunotoxin LMB-7

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesMeningeal Neoplasms

Study Officials

Darell D. Bigner, MD, PhD
Duke Cancer Institute
STUDY CHAIR

Study Design

Study Type: interventional
Phase: phase 1
Purpose: TREATMENT
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

May 19, 2004

Study Start

September 1997

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

September 2000

Actual (reported)

LMB-7 Immunotoxin in Treating Patients With Leptomeningeal Metastases

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

Primary Completion

Study Completion

First Posted

Conditions

Keywords

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

Primary Completion

Study Completion

First Posted

Conditions

Keywords

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations