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

Study Identifier
PCYC-0211
CT.gov Identifier
NCT00054795
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Solid Tumors (General)
  • Lung Cancer - Non-Small Cell Lung Cancer (NSCLC)
    • Study Drug
  • Motexafin Gadolinium
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion 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

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Phoenix, Arizona, United States
    Status
    Not applicable
    Location
    Fort Smith, Arkansas, United States
    Status
    Not applicable
    Location
    Little Rock, Arkansas, United States
    Status
    Not applicable
    Location
    Berkeley, California, United States
    Status
    Not applicable
    Location
    Concord, California, United States
    Status
    Not applicable
    Location
    Greenbrae, California, United States
    Status
    Not applicable
    Showing {first} - {last} of {total} Results