Study of Motexafin Gadolinium With Whole Brain Radiation Therapy Followed by Stereotactic Radiosurgery Boost in the Treatment of Patients With Brain Metastases
Phase II Trial of Motexafin Gadolinium With Whole Brain Radiation Therapy Followed by Stereotactic Radiosurgery Boost in the Treatment of Patients With Brain Metastases
1 other identifier
interventional
45
2 countries
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2005
CompletedFirst Posted
Study publicly available on registry
July 21, 2005
CompletedMay 9, 2014
May 1, 2014
July 14, 2005
May 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of irreversible Grade 3 or any Grade 4 or 5 neurologic radiation toxicities occuring within 3 months following SRS boost
Secondary Outcomes (3)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Aurora, Colorado, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Madison, Wisconsin, United States
Unknown Facility
Milwaukee, Wisconsin, United States
Unknown Facility
Montreal, Quebec, Canada
Unknown Facility
Québec, Quebec, Canada
Unknown Facility
Sherbrooke, Quebec, Canada
Related Publications (5)
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.
PMID: 12829672BACKGROUNDEvens 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.
PMID: 15627019BACKGROUNDBiaglow 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.
PMID: 15684606BACKGROUNDManon 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.
PMID: 15161323BACKGROUNDMeyers 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.
PMID: 14701778BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Minesh P Mehta, MD
University of Wisconsin, Madison
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2005
First Posted
July 21, 2005
Last Updated
May 9, 2014
Record last verified: 2014-05