Study of Motexafin Gadolinium With Whole Brain Radiation Therapy Followed by Stereotactic Radiosurgery Boost in the Treatment of Patients With Brain Metastases

Stopped early · Phase 2

Conditions studied: Neoplasm Metastasis, Brain Neoplasms

In brief

The primary purpose of the study is to evaluate if motexafin gadolinium with whole brain radiation therapy followed by a stereotactic radiosurgery boost is a safe and effective treatment.

Key facts

Study ID

NCT00121420

Run by

Pharmacyclics LLC.

People needed

45

Last updated by the study team

2014-05-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• Karnofsky performance status (KPS) ≥ 70
• Histologically confirmed malignancy with the presence of one to four intraparenchymal brain metastases
• Each patient must sign a study-specific Informed Consent form

You may not qualify if…

• Previous cranial radiation
• Complete resection of all known brain metastases
• Known leptomeningeal metastases
• Known liver metastases
• Clinical or radiologic evidence of progression (other than study lesion[s) within 1 month prior to enrollment
• Patients with metastases within 10 mm of the optic apparatus
• Patients with metastases in the brainstem, midbrain, pons, or medulla
• Planned chemotherapy during WBRT and/or SRS
• Uncontrolled hypertension
• Women who are pregnant or lactating
• and 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 > 3 x ULN
• Total bilirubin > 2 x ULN

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Aurora, Colorado, United States
• Study site — Cleveland, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Madison, Wisconsin, United States
• Study site — Milwaukee, Wisconsin, United States
• Study site — Montreal, Quebec, Canada
• Study site — Québec, Quebec, Canada
• Study site — Sherbrooke, Quebec, Canada

Full record on ClinicalTrials.gov

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