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



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

For Condition: Carcinoma, Non-Small-Cell Lung,Brain Neoplasms,Metastases, Neoplasm
Status: Recruiting
Sponsor(s): Pharmacyclics ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 550

Location and Contact Information:


Additional Information:
Study ID Numbers:
  PCYC-0211; 
Study Start Date: 
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054795

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