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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmacyclics LLC.
• Treatments: Motexafin gadolinium

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