Spots Global Cancer Trial Database for Radiation Therapy Plus Gadolinium Texaphyrin in Treating Patients With Brain Metastases
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Trial Identification
Brief Title: Radiation Therapy Plus Gadolinium Texaphyrin in Treating Patients With Brain Metastases
Official Title: Phase III Randomized Trial of Gadolinium Texaphyrin (PCI-0120) Injection as a Radiation Sensitizer in Patients Receiving Whole Brain Radiation Therapy for the Treatment of Brain Metastases
Study ID: NCT00003563
Conditions
Study Description
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Gadolinium texaphyrin may increase the effectiveness of radiation therapy by making tumor cells more sensitive to radiation. It is not yet known whether giving gadolinium texaphyrin with radiation therapy is more effective than radiation therapy alone in treating brain metastases. 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: OBJECTIVES: I. Determine the safety of gadolinium texaphyrin administered prior to whole brain radiotherapy in patients with brain metastases. II. Compare the efficacy and toxicity of whole brain radiotherapy with or without gadolinium texaphyrin in these patients. III. Assess the quality of life of these patients. 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Markus Renschler, MD
Affiliation: Pharmacyclics LLC.
Role: STUDY_CHAIR
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