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Completed

NCT Number: NCT00054795

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

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.

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Key information

Conditions

Brain Neoplasms Brain Diseases Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Central Nervous System Diseases Central Nervous System Neoplasms Lung Diseases Lung Neoplasms Metastases, Neoplasm Neoplasm Metastasis Neoplasm Recurrence, Local Neoplasms Neoplasms by Site Neoplastic Processes Nervous System Diseases Nervous System Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Liverpool, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

motexafin gadolinium

Drug

Sponsors and collaborators

Lead sponsor

Pharmacyclics LLC.

Industry

Registry information

Official study 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

Important dates

First posted
Feb 13, 2003
Registry last updated
May 8, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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