Radiation Therapy Plus Gadolinium Texaphyrin in Treating Patients With Brain Metastases
NCT ID: NCT00003563
Last Updated: 2013-10-31
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
430 participants
INTERVENTIONAL
1998-08-31
2005-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without gadolinium texaphyrin in treating patients who have brain metastases.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
OUTLINE: This is a randomized, two stage, multicenter study. Patients are stratified according to RTOG recursive partitioning analysis class (RPA class 1 vs class 2) and tumor type (breast vs lung vs other). Stage 1 (lead-in): All patients receive gadolinium texaphyrin IV over 5-10 minutes on the 10 days that they receive radiotherapy. Approximately 2-5 hours later, patients undergo whole brain radiotherapy. Stage 2 (randomization): Patients are randomized to one of two treatment arms. Patients in arm I undergo whole brain radiotherapy for 10 days. Patients in arm II receive gadolinium texaphyrin and radiotherapy as in stage 1. Quality of life is assessed on days 10 and 28, then monthly for 5 months, and then every 3 months thereafter. Patients are followed at day 28, then monthly for 5 months, and then every 3 months until death.
PROJECTED ACCRUAL: The lead-in phase will accrue at least 25-30 patients and the randomization phase will accrue 400 patients (200/arm) over a 12 month period.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
WBRT
3 Gy of WBRT daily for a total of 10 days
WBRT
3 GY of WBRT daily for a total of 10 days
MGd
IV does of 5.0 mg/kg MGd plus WBRT
WBRT
3 GY of WBRT daily for a total of 10 days
MGd
5.0 mg /kg MGd plus WBRT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
WBRT
3 GY of WBRT daily for a total of 10 days
MGd
5.0 mg /kg MGd plus WBRT
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No chemotherapy during and for 2 weeks after gadolinium texaphyrin therapy Endocrine therapy: Concurrent hormonal therapy allowed Radiotherapy: No prior cranial radiation, including prior stereotactic radiosurgery No plan for radiosurgery or radiation boost following whole brain radiotherapy Concurrent radiotherapy allowed to other sites, except kidneys and liver Surgery: No prior subtotal or total resection of brain metastases (except biopsies)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pharmacyclics LLC.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Markus Renschler, MD
Role: STUDY_CHAIR
Pharmacyclics LLC.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Marin Oncology Associates, Inc.
Greenbrae, California, United States
Kaiser Permanente Medical Group
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Beckman Research Institute, City of Hope
Los Angeles, California, United States
Radiation Oncology Center - Sacramento
Sacramento, California, United States
University of Colorado Cancer Center
Denver, Colorado, United States
Charlotte County Radiation Therapy Regional Center
Port Charlotte, Florida, United States
Emory Clinic
Atlanta, Georgia, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Hematology and Oncology Services - Metairie
Metairie, Louisiana, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Harper Hospital and Wayne State University
Detroit, Michigan, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States
North Memorial Research Center
Minneapolis, Minnesota, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
New Mexico Oncology-Hematology
Albuquerque, New Mexico, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Abington Hematology Oncology Associates
Meadowbrook, Pennsylvania, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Presbyterian-University Hospital
Pittsburgh, Pennsylvania, United States
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, United States
Vanderbilt Cancer Center
Nashville, Tennessee, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Scott and White Memorial Hospital
Temple, Texas, United States
Virginia Mason Medical Center
Seattle, Washington, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Cross Cancer Institute
Edmonton, Alberta, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Montreal General Hospital
Montreal, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Li J, Bentzen SM, Li J, Renschler M, Mehta MP. Relationship between neurocognitive function and quality of life after whole-brain radiotherapy in patients with brain metastasis. Int J Radiat Oncol Biol Phys. 2008 May 1;71(1):64-70. doi: 10.1016/j.ijrobp.2007.09.059.
Li J, Bentzen SM, Renschler M, Mehta MP. Regression after whole-brain radiation therapy for brain metastases correlates with survival and improved neurocognitive function. J Clin Oncol. 2007 Apr 1;25(10):1260-6. doi: 10.1200/JCO.2006.09.2536.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PCI-P120-9801
Identifier Type: -
Identifier Source: secondary_id
MSKCC-00088
Identifier Type: -
Identifier Source: secondary_id
UCLA-9808021
Identifier Type: -
Identifier Source: secondary_id
NCI-V98-1470
Identifier Type: -
Identifier Source: secondary_id
CDR0000066627
Identifier Type: -
Identifier Source: org_study_id