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

Randomized Phase III Trial of Xcytrin® (Motexafin Gadolinium) Injection for the Treatment of Brain Metastases in Patients With Non-Small Cell Lung Cancer Undergoing Whole Brain Radiation Therapy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00054795

Enrollment

550

Registered

2003-02-13

Start date

Unknown

Completion date

Unknown

Last updated

2007-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Neoplasms, Carcinoma, Non-Small-Cell Lung, Metastases, Neoplasm

Keywords

Brain Neoplasms/radiotherapy, Neoplasms/complications/prevention & control,, Neuropsychological Tests,, Metalloporphyrins/therapeutic use,, Combined Modality Therapy,, Drug therapy,, Quality of Life,, Cranial Irradiation,, Radiotherapy/Targeted,, Prospective Studies,, Neoplasm Recurrence/Local,, Treatment Outcome, Brain metastases, Brain Neoplasms/secondary, Non-small cell lung cancer

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.

Interventions

DRUGMotexafin Gadolinium

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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; * Women who are pregnant or lactating

Countries

Australia, Austria, Belgium, Canada, France, Germany, Netherlands, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026