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

Pharmacyclics

Status and phase

Completed

Phase 3

Conditions

Carcinoma, Non-Small-Cell Lung

Metastases, Neoplasm

Brain Neoplasms

Treatments

Drug: Motexafin Gadolinium

Study type

Interventional

Funder types

Industry

Identifiers

NCT00054795

PCYC-0211

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;