Study of Neurologic Progression With Motexafin Gadolinium and Radiation Therapy (SMART)
Phase 3
Completed
- Conditions
- Brain NeoplasmsCarcinoma, Non-Small-Cell LungMetastases, Neoplasm
- Registration Number
- NCT00054795
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 550
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method