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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Trial of Motexafin Gadolinium With Whole Brain Radiation Therapy Followed by Stereotactic Radiosurgery Boost in the Treatment of Patients With Brain Metastases

Conditions
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Neoplasm Metastasis, Brain Neoplasms

Intervention / Treatment
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* Drug: Motexafin gadolinium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Motexafin gadolinium|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of irreversible Grade 3 or any Grade 4 or 5 neurologic radiation toxicities occuring within 3 months following SRS boost |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neoplasm metastasis, Brain Neoplasms/secondary, Brain neoplasms/radiotherapy, Brain metastasis, Cranial irradiation, Radiosurgery, Lung Neoplasms, Breast Neoplasms, Kidney Neoplasms, Melanoma, Radiotherapy, Carcinoma, non-small cell lung