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Radiation Therapy Plus Gadolinium Texaphyrin in Treating Patients With Brain Metastases Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Radiation Therapy Plus Gadolinium Texaphyrin in Treating Patients With Brain Metastases conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Radiation Therapy Plus Gadolinium Texaphyrin in Treating Patients With Brain Metastases Clinical research trials and Radiation Therapy Plus Gadolinium Texaphyrin in Treating Patients With Brain Metastases healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Radiation Therapy Plus Gadolinium Texaphyrin in Treating Patients With Brain Metastases. Radiation Therapy Plus Gadolinium Texaphyrin in Treating Patients With Brain Metastases Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Radiation Therapy Plus Gadolinium Texaphyrin in Treating Patients With Brain Metastases clinical trial. Participants typically obtain the most effective healthcare available for their Radiation Therapy Plus Gadolinium Texaphyrin in Treating Patients With Brain Metastases condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Radiation Therapy Plus Gadolinium Texaphyrin in Treating Patients With Brain Metastases  Radiation Therapy Plus Gadolinium Texaphyrin in Treating Patients With Brain Metastases
Radiation Therapy Plus Gadolinium Texaphyrin in Treating Patients With Brain Metastases
For Condition: brain metastases,Quality of Life,unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): Pharmacyclics ,
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven solid tumor with parenchymal brain metastasis; Solitary metastasis eligible only if refused surgery or surgical resection deemed inappropriate; No leptomeningeal metastases or subarachnoid spread of tumor - No small cell lung cancer, germ cell tumors, lymphoma, or leukemia - No liver metastases, unless from breast cancer - No more than 1 site of extracranial metastases (multiple bone or lung metastases count as one site), unless from breast cancer - Hormone receptor status: Not specified --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) --Patient Characteristics-- - Age: 18 and over - Menopausal status: Not specified - Performance status: Karnofsky 70-100% - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 50,000/mm3 - Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN); AST and ALT no greater than 2 times ULN - Renal: Creatinine no greater than 2.0 mg/mL - Other: No history of porphyria; No history of G6PD deficiency; HIV negative; No other major medical illnesses; No major psychiatric impairment; Not pregnant or nursing; Negative pregnancy test
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarkusRenschler, Study Chair, Pharmacyclics
New Mexico Oncology-Hematology
Albuquerque, New Mexico, 87102
United States
Scott and White Memorial Hospital
Temple, Texas, 76508
United States
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Canada
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45219
United States
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2
Canada
Abington Hematology Oncology Associates
Meadowbrook, Pennsylvania, 18974
United States
Charlotte County Radiation Therapy Regional Center
Port Charlotte, Florida, 33952
United States
Thompson Cancer Survival Center
Knoxville, Tennessee, 37916
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
Marin Oncology Associates, Inc.
Greenbrae, California, 94904
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Emory Clinic
Atlanta, Georgia, 30365
United States
Harper Hospital and Wayne State University
Detroit, Michigan, 48201
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, 18501
United States
Vanderbilt Cancer Center
Nashville, Tennessee, 37232-6838
United States
Kaiser Permanente Medical Group
Los Angeles, California, 90027
United States
Presbyterian-University Hospital
Pittsburgh, Pennsylvania, 15213
United States
Beckman Research Institute, City of Hope
Los Angeles, California, 91010
United States
North Memorial Research Center
Minneapolis, Minnesota, 55442-2900
United States
University of Colorado Cancer Center
Denver, Colorado, 80262
United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107
United States
Virginia Mason Medical Center
Seattle, Washington, 98111
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
Hematology and Oncology Services - Metairie
Metairie, Louisiana, 70006
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5265
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
United States
Radiation Oncology Center - Sacramento
Sacramento, California, 95816
United States
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Canada
Additional Information:
Study ID Numbers: CDR0000066627; PCI-P120-9801,NCI-V98-1470,MSKCC-00088,UCLA-9808021
Study Start Date: August 1998
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003563
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Temozolomide in Treating Patients With Solid Tumors That Have Spread to the Brain
2. Radiation Therapy in Preventing CNS Metastases in Patients With Non-Small Cell Lung Cancer
3. Stereotactic Radiation Therapy in Treating Patients With Brain Metastases
4. Irinotecan and Whole-Brain Radiation Therapy in Treating Patients With Unresectable Brain Metastases From Non-Small Cell Lung Cancer
5. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Pennsylvania Clinical Trials
Other Pittsburgh Clinical Trials
Radiation Therapy Plus Gadolinium Texaphyrin in Treating Patients With Brain Metastases
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