Study of Motexafin Gadolinium With Whole Brain Radiation Therapy Followed by Stereotactic Radiosurgery Boost in the Treatment of Patients With Brain Metastases
Phase 2
Terminated
- Conditions
- Neoplasm MetastasisBrain Neoplasms
- Registration Number
- NCT00121420
- Lead Sponsor
- Pharmacyclics LLC.
- 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 motexafin gadolinium. Patients will be followed for radiologic response, neurologic progression, and neurocognitive progression.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 45
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Rate of irreversible Grade 3 or any Grade 4 or 5 neurologic radiation toxicities occuring within 3 months following SRS boost
- Secondary Outcome Measures
Name Time Method Change in lesion size and number between screening MRI and SRS treatment -planning MRI Time to neuroligic progression or death with evidence of neurologic progression Time to neurocognitive progression