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

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

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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