NCT00040573

Brief Summary

This drug is being developed to treat a type of brain cancer, glioma. This study was designed to determine a safe and well tolerated dose. Patients must have had prior treatment for their glioma and be eligible for removal of their recurring tumor.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2002

Geographic Reach
1 country

3 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

June 1, 2002

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 2, 2002

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
Last Updated

March 31, 2009

Status Verified

March 1, 2009

First QC Date

June 29, 2002

Last Update Submit

March 30, 2009

Conditions

GliomaBrain Neoplasm

Keywords

Brain neoplasmClinical trial, phase I/II

Interventions

131I-TM-601DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* Patient must have given informed consent * Patient must have histologically confirmed supratentorial malignant glioma * Patients must have recovered from toxicity of prior therapy * Patients must be eligble for resection of the recurrent tumor

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

Sponsors & Collaborators

Study Sites (3)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-3295, United States

Location

City of Hope

Duarte, California, 91010-3000, United States

Location

Saint Louis University

St Louis, Missouri, 63110-0250, United States

Location

MeSH Terms

Conditions

GliomaBrain Neoplasms

Interventions

Chlorotoxin

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Diana M Hablitz, MSNCRNP

    TransMolecular

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 29, 2002

First Posted

July 2, 2002

Study Start

June 1, 2002

Study Completion

August 1, 2003

Last Updated

March 31, 2009

Record last verified: 2009-03

Locations

US(3)