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

Completed · Phase 3

Conditions studied: Brain Neoplasms, Carcinoma, Non-Small-Cell Lung, Metastases, Neoplasm

In brief

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.

Key facts

Study ID

NCT00054795

Run by

Pharmacyclics LLC.

People needed

550

Last updated by the study team

2007-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Fort Smith, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Berkeley, California, United States
• Study site — Concord, California, United States
• Study site — Greenbrae, California, United States
• Study site — Los Angeles, California, United States
• Study site — Montebello, California, United States
• Study site — Sacramento, California, United States
• Study site — Stanford, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Hartford, Connecticut, United States
• Study site — New Haven, Connecticut, United States
• Study site — Chicago, Illinois, United States
• Study site — Fort Wayne, Indiana, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Washington D.C, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Grand Rapids, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — St Louis, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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