Status:
TERMINATED
Study of Motexafin Gadolinium With Whole Brain Radiation Therapy Followed by Stereotactic Radiosurgery Boost in the Treatment of Patients With Brain Metastases
Lead Sponsor:
Pharmacyclics LLC.
Conditions:
Neoplasm Metastasis
Brain Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
Patients will receive three weeks of whole brain radiation therapy concurrent with daily motexafin gadolinium during weeks 2 and 3, followed by a stereotactic radiosurgery boost concurrent with motexa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00121420
Last Update
May 9 2014
Active Locations (12)
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1
Phoenix, Arizona, United States
2
Aurora, Colorado, United States
3
Cleveland, Ohio, United States
4
Columbus, Ohio, United States