Back to resultsStudy of Motexafin Gadolinium With Whole Brain Radiation Therapy Followed by Stereotactic Radiosurgery Boost in the Treatment of Patients With Brain Metastases
Primary Purpose
Neoplasm Metastasis, Brain Neoplasms
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Motexafin gadolinium
Sponsored by
About this trial
This is an interventional treatment trial for Neoplasm Metastasis focused on measuring Brain Neoplasms/secondary, Brain neoplasms/radiotherapy, Brain metastasis, Neoplasm metastasis, Cranial irradiation, Radiosurgery, Lung Neoplasms, Breast Neoplasms, Kidney Neoplasms, Melanoma, Radiotherapy, Carcinoma, non-small cell lung
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Rate of irreversible Grade 3 or any Grade 4 or 5 neurologic radiation toxicities occuring within 3 months following SRS boost
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00121420
Brief Title
Study of Motexafin Gadolinium With Whole Brain Radiation Therapy Followed by Stereotactic Radiosurgery Boost in the Treatment of Patients With Brain Metastases
Official Title
Phase II Trial of Motexafin Gadolinium With Whole Brain Radiation Therapy Followed by Stereotactic Radiosurgery Boost in the Treatment of Patients With Brain Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Study Start Date
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Primary Completion Date
undefined (undefined)
Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmacyclics LLC.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm Metastasis, Brain Neoplasms
Keywords
Brain Neoplasms/secondary, Brain neoplasms/radiotherapy, Brain metastasis, Neoplasm metastasis, Cranial irradiation, Radiosurgery, Lung Neoplasms, Breast Neoplasms, Kidney Neoplasms, Melanoma, Radiotherapy, Carcinoma, non-small cell lung
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Motexafin gadolinium
Primary Outcome Measure Information:
Title
Rate of irreversible Grade 3 or any Grade 4 or 5 neurologic radiation toxicities occuring within 3 months following SRS boost
Secondary Outcome Measure Information:
Title
Change in lesion size and number between screening MRI and SRS treatment -planning MRI
Title
Time to neuroligic progression or death with evidence of neurologic progression
Title
Time to neurocognitive progression
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minesh P Mehta, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Study Chair
Facility Information:
City
Phoenix
State/Province
Arizona
Country
United States
City
Aurora
State/Province
Colorado
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Madison
State/Province
Wisconsin
Country
United States
City
Milwaukee
State/Province
Wisconsin
Country
United States
City
Montreal
State/Province
Quebec
Country
Canada
City
Quebec City
State/Province
Quebec
Country
Canada
City
Sherbrooke
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
12829672
Citation
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.
Results Reference
background
PubMed Identifier
15627019
Citation
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.
Results Reference
background
PubMed Identifier
15684606
Citation
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.
Results Reference
background
PubMed Identifier
15161323
Citation
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.
Results Reference
background
PubMed Identifier
14701778
Citation
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.
Results Reference
background
Links:
URL
http://www.braintumor.org
Description
National Brain Tumor Foundation
URL
http://pharmacyclics.com
Description
Pharmacyclics
Learn more about this trial
Study of Motexafin Gadolinium With Whole Brain Radiation Therapy Followed by Stereotactic Radiosurgery Boost in the Treatment of Patients With Brain Metastases
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