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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00054795
Recruitment Status : Completed
First Posted : February 13, 2003
Last Update Posted : May 8, 2007
Information provided by:
Pharmacyclics LLC.

Brief 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 alone.

Condition or disease Intervention/treatment Phase
Brain Neoplasms Carcinoma, Non-Small-Cell Lung Metastases, Neoplasm Drug: Motexafin Gadolinium Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00054795

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Sponsors and Collaborators
Pharmacyclics LLC.
Additional Information:
Layout table for additonal information Identifier: NCT00054795    
Obsolete Identifiers: NCT00066820
Other Study ID Numbers: PCYC-0211
First Posted: February 13, 2003    Key Record Dates
Last Update Posted: May 8, 2007
Last Verified: May 2007
Keywords provided by Pharmacyclics LLC.:
Brain Neoplasms/radiotherapy
Neoplasms/complications/prevention & control,
Neuropsychological Tests,
Metalloporphyrins/therapeutic use,
Combined Modality Therapy,
Drug therapy,
Quality of Life,
Cranial Irradiation,
Prospective Studies,
Neoplasm Recurrence/Local,
Treatment Outcome
Brain metastases
Brain Neoplasms/secondary
Non-small cell lung cancer
Additional relevant MeSH terms:
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Neoplasm Metastasis
Carcinoma, Non-Small-Cell Lung
Brain Neoplasms
Neoplastic Processes
Pathologic Processes
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Motexafin gadolinium
Antineoplastic Agents
Photosensitizing Agents
Dermatologic Agents