Study of Neurologic Progression With Motexafin Gadolinium and Radiation Therapy (SMART)

May 4, 2007 updated by: Pharmacyclics LLC.

Randomized Phase III Trial of Xcytrin® (Motexafin Gadolinium) Injection for the Treatment of Brain Metastases in Patients With Non-Small Cell Lung Cancer Undergoing Whole Brain Radiation Therapy

The primary purpose of the study is to determine if patients with brain metastases from non-small cell lung cancer treated with Motexafin Gadolinium and whole brain radiation therapy retain their neurologic function and ability to think for a longer time compared to patients treated with whole brain radiation therapy alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

550

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia
      • St. Leonards, New South Wales, Australia
      • Wollongong, New South Wales, Australia
    • Queensland
      • Herston, Queensland, Australia
      • Woollongabba, Queensland, Australia
    • Victoria
      • East Melbourne, Victoria, Australia
      • Footscray, Victoria, Australia
      • Geelong, Victoria, Australia
      • Heidelberg, Victoria, Australia
  • Austria
      • Linz, Austria
      • Wien, Austria
  • Belgium
      • Antwerpen, Belgium
      • Bruxelles, Belgium
      • Haine-Saint-Paul, Belgium
      • Leuven, Belgium
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
      • Edmonton, Alberta, Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
    • Ontario
      • Hamilton, Ontario, Canada
      • Kingston, Ontario, Canada
      • London, Ontario, Canada
      • Ottawa, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
      • Quebec City, Quebec, Canada
      • Sherbrooke, Quebec, Canada
  • France
      • Caen, France
      • Lille, France
      • Lyon, France
      • Montbeliard, France
      • Nice, France
      • Pierre Benite, France
      • Rennes, France
      • Saint Herblain, France
      • Vandoeuvre Les Nancy, France
      • Villejuif, France
  • Germany
      • Aachen, Germany
      • Berlin, Germany
      • Essen, Germany
      • Freiberg, Germany
      • Hamburg, Germany
      • Heidelberg, Germany
      • Herne, Germany
      • Magdeburg, Germany
      • Munchen, Germany
  • Netherlands
      • Gravenhage, Netherlands
      • Heerlen, Netherlands
      • Rotterdam, Netherlands
  • United States
    • Arizona
      • Phoenix, Arizona, United States
    • Arkansas
      • Fort Smith, Arkansas, United States
      • Little Rock, Arkansas, United States
    • California
      • Berkeley, California, United States
      • Concord, California, United States
      • Greenbrae, California, United States
      • Los Angeles, California, United States
      • Montebello, California, United States
      • Sacramento, California, United States
      • Stanford, California, United States
    • Colorado
      • Aurora, Colorado, United States
    • Connecticut
      • Hartford, Connecticut, United States
      • New Haven, Connecticut, United States
    • Illinois
      • Chicago, Illinois, United States
    • Indiana
      • Fort Wayne, Indiana, United States
      • Indianapolis, Indiana, United States
    • Louisiana
      • Shreveport, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Washington D.C, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Detroit, Michigan, United States
      • Grand Rapids, Michigan, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
    • Missouri
      • St. Louis, Missouri, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • New Jersey
      • Camden, New Jersey, United States
      • Morristown, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • New York, New York, United States
      • Rochester, New York, United States
    • Ohio
      • Akron, Ohio, United States
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
    • Tennessee
      • Knoxville, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Houston, Texas, United States
      • Laredo, Texas, United States
      • San Antonio, Texas, United States
      • Tyler, Texas, United States
    • Virginia
      • Charlottesville, Virginia, United States
    • Wisconsin
      • Madison, Wisconsin, United States
      • Milwaukee, Wisconsin, United States

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults (≥18 years old) with radiologically proven parenchymal brain metastases from histologically confirmed non-small cell lung cancer;
  • KPS score of ≥70;
  • Each patient must sign a study-specific Informed Consent form

Exclusion Criteria:

  • Liver metastases;
  • Extracranial metastases in two or more organs;
  • Known leptomeningeal metastases or subarachnoid spread of tumor;
  • Prior whole brain radiation;
  • Plan to use radiosurgery or radiation boost after completion of WBRT;
  • Planned chemotherapy during study treatment (prior and subsequent chemotherapy is allowed);
  • Prior total resection of a single brain metastasis;
  • Laboratory values as follows:

LDH > 1.3 x upper limit of normal (ULN); ANC < 1500 /mm³; Platelets < 50,000 /mm³; Creatinine > 2.0 mg/dL; AST or ALT > 2 x ULN; Total bilirubin > 2 x ULN;

  • Women who are pregnant or lactating

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

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

Sponsor

Pharmacyclics LLC.

Publications and helpful links

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

General Publications

Helpful Links

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

First Submitted

February 10, 2003

First Submitted That Met QC Criteria

February 12, 2003

First Posted (Estimate)

February 13, 2003

Study Record Updates

Last Update Posted (Estimate)

May 8, 2007

Last Update Submitted That Met QC Criteria

May 4, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCYC-0211

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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