Study of Motexafin Gadolinium With Whole Brain Radiation Therapy Followed by Stereotactic Radiosurgery Boost in the Treatment of Patients With Brain Metastases
NCT ID: NCT00121420
Last Updated: 2014-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
45 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Motexafin gadolinium
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Pharmacyclics LLC.
INDUSTRY
Responsible Party
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Principal Investigators
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Minesh P Mehta, MD
Role: STUDY_CHAIR
University of Wisconsin, Madison
Locations
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Phoenix, Arizona, United States
Aurora, Colorado, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Dallas, Texas, United States
Houston, Texas, United States
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Montreal, Quebec, Canada
Québec, Quebec, Canada
Sherbrooke, Quebec, Canada
Countries
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References
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Mehta MP, Rodrigus P, Terhaard CH, Rao A, Suh J, Roa W, Souhami L, Bezjak A, Leibenhaut M, Komaki R, Schultz C, Timmerman R, Curran W, Smith J, Phan SC, Miller RA, Renschler MF. Survival and neurologic outcomes in a randomized trial of motexafin gadolinium and whole-brain radiation therapy in brain metastases. J Clin Oncol. 2003 Jul 1;21(13):2529-36. doi: 10.1200/JCO.2003.12.122.
Evens AM. Motexafin gadolinium: a redox-active tumor selective agent for the treatment of cancer. Curr Opin Oncol. 2004 Nov;16(6):576-80. doi: 10.1097/01.cco.0000142073.29850.98.
Biaglow JE, Miller RA. The thioredoxin reductase/thioredoxin system: novel redox targets for cancer therapy. Cancer Biol Ther. 2005 Jan;4(1):6-13. doi: 10.4161/cbt.4.1.1434. Epub 2004 Jan 8.
Manon R, Hui S, Chinnaiyan P, Suh J, Chang E, Timmerman R, Phan S, Das R, Mehta M. The impact of mid-treatment MRI on defining boost volumes in the radiation treatment of glioblastoma multiforme. Technol Cancer Res Treat. 2004 Jun;3(3):303-7. doi: 10.1177/153303460400300308.
Meyers CA, Smith JA, Bezjak A, Mehta MP, Liebmann J, Illidge T, Kunkler I, Caudrelier JM, Eisenberg PD, Meerwaldt J, Siemers R, Carrie C, Gaspar LE, Curran W, Phan SC, Miller RA, Renschler MF. Neurocognitive function and progression in patients with brain metastases treated with whole-brain radiation and motexafin gadolinium: results of a randomized phase III trial. J Clin Oncol. 2004 Jan 1;22(1):157-65. doi: 10.1200/JCO.2004.05.128.
Related Links
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National Brain Tumor Foundation
Pharmacyclics
Other Identifiers
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PCYC-0224
Identifier Type: -
Identifier Source: org_study_id
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