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Brain NeoplasmsPhase 3NCT00054795

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

A Phase 3 study testing Motexafin Gadolinium in people with Brain Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Pharmacyclics LLC. at 92 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Motexafin Gadolinium
How many people
550 participants
Where
92 sitesin 8 countries
Study dates
Start not givento not given
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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);
Show all 10Show fewer
  • 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

Trial locations and contacts

92 sites in 8 countries.

92 sites in 8 countries

United States44 sites

  • Study site

    Akron, Ohio

  • Study site

    Albuquerque, New Mexico

  • Study site

    Aurora, Colorado

  • Study site

    Baltimore, Maryland

  • Study site

    Berkeley, California

  • Study site

    Boston, Massachusetts

  • Study site

    Camden, New Jersey

  • Study site

    Charlottesville, Virginia

  • Study site

    Chicago, Illinois

  • Study site

    Cleveland, Ohio

  • Study site

    Columbus, Ohio

  • Study site

    Concord, California

  • Study site

    Detroit, Michigan

  • Study site

    Fort Smith, Arkansas

  • Study site

    Fort Wayne, Indiana

  • Study site

    Grand Rapids, Michigan

  • Study site

    Greenbrae, California

  • Study site

    Hartford, Connecticut

  • Study site

    Hershey, Pennsylvania

  • Study site

    Houston, Texas

  • Study site

    Indianapolis, Indiana

  • Study site

    Knoxville, Tennessee

  • Study site

    Laredo, Texas

  • Study site

    Little Rock, Arkansas

  • Study site

    Los Angeles, California

  • Study site

    Madison, Wisconsin

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Minneapolis, Minnesota

  • Study site

    Montebello, California

  • Study site

    Morristown, New Jersey

  • Study site

    Nashville, Tennessee

  • Study site

    New Haven, Connecticut

  • Study site

    New York, New York

  • Study site

    Omaha, Nebraska

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    Rochester, New York

  • Study site

    Sacramento, California

  • Study site

    San Antonio, Texas

  • Study site

    Shreveport, Louisiana

  • Study site

    St Louis, Missouri

  • Study site

    Stanford, California

  • Study site

    Tyler, Texas

  • Study site

    Washington D.C, Maryland

Other trials in United States

Canada11 sites

  • Study site

    Calgary, Alberta

  • Study site

    Edmonton, Alberta

  • Study site

    Halifax, Nova Scotia

  • Study site

    Hamilton, Ontario

  • Study site

    Kingston, Ontario

  • Study site

    London, Ontario

  • Study site

    Montreal, Quebec

  • Study site

    Ottawa, Ontario

  • Study site

    Québec, Quebec

  • Study site

    Sherbrooke, Quebec

  • Study site

    Toronto, Ontario

Other trials in Canada

France10 sites

  • Study site

    Caen

  • Study site

    Lille

  • Study site

    Lyon

  • Study site

    Montbéliard

  • Study site

    Nice

  • Study site

    Pierre-Bénite

  • Study site

    Rennes

  • Study site

    Saint-Herblain

  • Study site

    Vandœuvre-lès-Nancy

  • Study site

    Villejuif

Other trials in France

Australia9 sites

  • Study site

    East Melbourne, Victoria

  • Study site

    Footscray, Victoria

  • Study site

    Geelong, Victoria

  • Study site

    Heidelberg, Victoria

  • Study site

    Herston, Queensland

  • Study site

    Liverpool, New South Wales

  • Study site

    St Leonards, New South Wales

  • Study site

    Wollongong, New South Wales

  • Study site

    Woollongabba, Queensland

Other trials in Australia

Germany9 sites

  • Study site

    Aachen

  • Study site

    Berlin

  • Study site

    Essen

  • Study site

    Freiberg

  • Study site

    Hamburg

  • Study site

    Heidelberg

  • Study site

    Herne

  • Study site

    Magdeburg

  • Study site

    München

Other trials in Germany

Belgium4 sites

  • Study site

    Antwerp

  • Study site

    Brussels

  • Study site

    Haine-Saint-Paul

  • Study site

    Leuven

Other trials in Belgium

Netherlands3 sites

  • Study site

    Gravenhage

  • Study site

    Heerlen

  • Study site

    Rotterdam

Other trials in Netherlands

Austria2 sites

  • Study site

    Linz

  • Study site

    Vienna

Other trials in Austria

About this study

Official title: 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.

Being tested
Motexafin Gadolinium
Keywords
Brain Neoplasms/radiotherapy, Neoplasms/complications/prevention & control,, Neuropsychological Tests,, Metalloporphyrins/therapeutic use,, Combined Modality Therapy,, Drug therapy,, Quality of Life,, Cranial Irradiation,, Radiotherapy/Targeted,, Prospective Studies,, Neoplasm Recurrence/Local,, Treatment Outcome, Brain metastases, Brain Neoplasms/secondary, Non-small cell lung cancer
Medical subject headings
Brain Neoplasms, Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis, Neoplasms, Neoplasm Recurrence, Local

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motexafin GadoliniumDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2003 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
550 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00054795
Sponsor's protocol ID
PCYC-0211
Status last verified
May 2007
First submitted
10 Feb 2003
Last updated
8 May 2007
Results posted
No

Publications

  • Mehta MP, Shapiro WR, Glantz MJ, Patchell RA, Weitzner MA, Meyers CA, Schultz CJ, Roa WH, Leibenhaut M, Ford J, Curran W, Phan S, Smith JA, Miller RA, Renschler MF. Lead-in phase to randomized trial of motexafin gadolinium and whole-brain radiation for patients with brain metastases: centralized assessment of magnetic resonance imaging, neurocognitive, and neurologic end points. J Clin Oncol. 2002 Aug 15;20(16):3445-53. doi: 10.1200/JCO.2002.07.500.

    PubMed 12177105

  • Carde P, Timmerman R, Mehta MP, Koprowski CD, Ford J, Tishler RB, Miles D, Miller RA, Renschler MF. Multicenter phase Ib/II trial of the radiation enhancer motexafin gadolinium in patients with brain metastases. J Clin Oncol. 2001 Apr 1;19(7):2074-83. doi: 10.1200/JCO.2001.19.7.2074.

    PubMed 11283141

  • Rosenthal DI, Nurenberg P, Becerra CR, Frenkel EP, Carbone DP, Lum BL, Miller R, Engel J, Young S, Miles D, Renschler MF. A phase I single-dose trial of gadolinium texaphyrin (Gd-Tex), a tumor selective radiation sensitizer detectable by magnetic resonance imaging. Clin Cancer Res. 1999 Apr;5(4):739-45.

    PubMed 10213207

  • Magda D, Lepp C, Gerasimchuk N, Lee I, Sessler JL, Lin A, Biaglow JE, Miller RA. Redox cycling by motexafin gadolinium enhances cellular response to ionizing radiation by forming reactive oxygen species. Int J Radiat Oncol Biol Phys. 2001 Nov 15;51(4):1025-36. doi: 10.1016/s0360-3016(01)01810-7.

    PubMed 11704327

  • Miller RA, Woodburn K, Fan Q, Renschler MF, Sessler JL, Koutcher JA. In vivo animal studies with gadolinium (III) texaphyrin as a radiation enhancer. Int J Radiat Oncol Biol Phys. 1999 Nov 1;45(4):981-9. doi: 10.1016/s0360-3016(99)00274-6.

    PubMed 10571206

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Motexafin Gadolinium in people with Brain Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Pharmacyclics LLC. at 92 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in United States, Canada, France, Australia, Germany and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00054795, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2007.

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